indian council of medical research - ctri · web viewposter presentation in annual all gujarat...

74
Institutional Review Board (IRB)/ [Human Ethics Committee (HEC)] સસસસસસ સસસસસ સસસસસસસસસસસ, સસસસસસ. Govt. Medical College, Bhavnagar-364001 સસ.સસ સસસસસસસ સસસસ, સસસ સસસ, સસસસસસ - ૩૬૪૦૦૧ (સસસસસસ), Behind S.T. Stand , Jail Road, Bhavnagar 364001 (Gujarat) India. Phone no (0278) 2430808 Web site: www.bvnmedicol.org Fax no.(0278) 2422011 No. GMCB / ………IRB (HEC) / . . . . . . . .. . . . . . . . . . . .. . ./ 2011. Form to be filled by the Principal Investigator (PI) for submission to Institutional Review Board (IRB)/[Human Ethics Committee (HEC)] ( Attach with each copy of the proposal ) Office of the Dean, Page 1 of 74 For Office Use: Received Date: Received after scrutinization: IRB Approval Date: IRB (HEC) No.. . . . . . . . . / 2011 . . . . . . . . . . . . . no. …/2011 (... . . . . . . ... .. . .) Affix Passport size recent photograph

Upload: hoangxuyen

Post on 18-Apr-2018

243 views

Category:

Documents


4 download

TRANSCRIPT

Page 1: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Institutional Review Board (IRB)/ [Human Ethics Committee (HEC)]સરકારી તબીબી મહાવિ�દ્યાલય, ભા�નગર. Govt. Medical College, Bhavnagar-364001

એસ.ટી સે્ટન્ડ પાછળ, જેલ રોડ, ભા�નગર - ૩૬૪૦૦૧ (ગુજરાત), Behind S.T. Stand , Jail Road, Bhavnagar 364001 (Gujarat) India.

Phone no (0278) 2430808 Web site: www.bvnmedicol.org Fax no.(0278) 2422011

No. GMCB / ………IRB (HEC) / . . . . . . . .. . . . . . . . . . . .. . ./ 2011. Form to be filled by the Principal Investigator (PI) for submission toInstitutional Review Board (IRB)/[Human Ethics Committee (HEC)]

( Attach with each copy of the proposal )

Office of the Dean, Govt. Medical College,Bhavnagar 364001(Gujarat)Date: / /2011

Research / Dissertation Proposal Submission Proforma :Before submitting the proposal to Institutional Review Board (IRB) / [Human Ethics Committee (HEC)] please discuss it in the department’s scientific meeting and produce a attendance sheet and power point presentation of that meeting.

Research Proposal Title: (In Times New Roman fonts, size:16, in capital letters ) TO STUDY THE USE OF BOTULINUM TOXIN IN OPHTHALMIC PLASTIC DISORDERS. ____________________________________________________________________________________________________________________

Page 1 of 52

For Office Use:Received Date:Received after scrutinization:IRB Approval Date:IRB (HEC) No.. . . . . . . . . / 2011. . . . . . . . . . . . . no. …/2011 (... . . . . . . ... .. . .)

Govt. Medical College, Bhavnagar.

Date: / /2011

Affix Passport size recent photograph only in two copies of proposal

Page 2: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Name, Designation

&Qualifications

AddressTel no. & Fax Nos.

Email ID

Signature

PI Dr Yogesh P Parmar

Room no.401 ,Dhanvantary PG hostel-2 ,Sir-T Hospital ,Bhavnagar.Mo.no.9099971818.Email [email protected]

Co-PI / Collaborators

1.

Dr Nilesh V Parekh

22 vinay,behind central salt,opp. New filter tank,Bhavnagar .Mo.no – 9825252673.E mail ID - [email protected]

2.

Dr Neepa R Gohil ‘YASHANSHU ’ Bunglaw.Plot no.83.Bhavnagar.Mo no.9909978072.Email [email protected]

3.

Dr Hetal J Patel Room no.504 ,Dhanvantary PG hostel-2 ,Sir-T Hospital ,Bhavnagar.Mo.no- 9099987070Email [email protected]

Please attach detailed Curriculum Vitae of all Investigators dated and signed by the investigators(with subject specific publications limited to previous 5 years).

Sponsor Information :1. Indian a) Government Central State Institutional b) Private2. International Government Private UN agencies

Page 2 of 52

Page 3: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

3. Industry National Multinational

Contact Address of Sponsor: Department of Ophthalmology , Government Medical College , Bhavnagar, Gujarat.

Total Budget: In Indian Currency: Rs. (In number) Rs.65,000 – Rs.75,000. Rs. (In Words) Rs. Sixty five thousand – Rs. Seventy five thousand.

1.Type of Study :Epidemiological Basic Sciences Animal studies

Clinical: Single center Multicentric Behavioral

2. Status of Review: New Revised

3. Clinical Trials: Drug /Vaccines/Device/Herbal Remedies :

i. Does the study involve use of : Drug Devices Vaccines

Indian Systems of Medicine/ Any other NA Alternate System of Medicine

ii. Is it approved and marketed In India UK & Europe USA

Other countries, specifyiii. Does it involve a change in use, dosage, route of administration?If yes, whether DCGI’s /Any other Regulatory authority’s Permission is obtained?If yes, Date of permission :

Yes

Yes

No√

No

iv. Is it an Investigational New Drug?

If yes, IND No:

Yes No√

a). Investigator’s Brochure submitted Yes No√b). In vitro studies data Yes No√c). Preclinical Studies done Yes No√

d). Clinical Study is : Phase I Phase II Phase III Phase IV

Page 3 of 52

Page 4: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

e). Are you aware if this study/similar study is being done elswhere ? If Yes, attach details

Yes No√

4. Brief description of the proposal (In Times New Roman fonts double spacing, size: 14 ) – in following points :a .Introduction, b. Review of literature - submit hard copy of few published papers. c. Aim(s) & objectives, d. Justification for study, e. Methodology describing the potential risks & benefits, f. Outcome measures, g. Statistical analysis and h. Whether it is of national / State of Gujarat significance with rationale (Attach sheet with maximum 500 words):

5. Subject selection:i. Number of Subjects : 25ii. Duration of study : 1 year

iii. Will subjects from both sexes be recruited Yes√ Noiv. Inclusion / exclusion criteria given Yes√ Nov. Type of subjects Volunteers Patients

vi. Vulnerable subjects Yes No(Tick the appropriate boxes) pregnant women children elderly fetus illiterate handicapped

terminally ill seriously ill mentally challengedeconomically &

socially backward any othervii. Special group subjects Yes No

(Tick the appropriate boxes) captives institutionalized employees students nurses/dependent armedany other staff forces

6. Privacy and confidentiality i. Study involves - Direct Identifiers

Indirect Identifiers/coded Completely anonymised/ delinked

ii. Confidential handling of data by staff Yes√ No

Page 4 of 52

Page 5: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

7. Use of biological/ hazardous materials i. Use of fetal tissue or abortus

Yes No√

ii. Use of organs or body fluids Yes No√ iii. Use of recombinant/gene therapy

If yes, has Department of Biotechnology (DBT) approval for rDNA products been obtained?

Yes

Yes

No√

No

iv. Use of pre-existing/stored/left over samples Yes No√ v. Collection for banking/future research Yes No√

vi. Use of ionizing radiation/radioisotopes

If yes,has Bhabha Atomic Research Centre (BARC) approval for Radioactive Isotopes been obtained?

Yes

Yes

No√

No

vii. Use of Infectious/ bio hazardous specimens Yes No√ viii. Proper disposal of material Yes√ No ix. Will any sample collected from the patients be sent abroad ? If Yes, justify with details of collaborators

Yes No√

a) Is the proposal being submitted for clearance from Health Ministry’s Screening Committee (HMSC) for International collaboration?

Yes No

Page 5 of 52

Page 6: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

b) Sample will be sent abroad because (Tick appropriate box):

Facility not available in India Facility in India inaccessible Facility available but not being accessed. If so, reasons…

8. Consent : *Written Oral Audio-visual i. Consent form : (tick the included elements)

Understandable language Alternatives to participationStatement that study involves research Confidentiality of recordsSponsor of study Contact informationPurpose and procedures Statement that consent is voluntaryRisks & Discomforts Right to withdrawBenefits Consent for future use of biological material Compensation for participation Benefits if any on future commercialization Compensation for study related injury eg. genetic basis for drug development

*If written consent is not obtained, give reasons: - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

- - - -- - - - - -- - - -- - - - - -- - - - - -- - - - -- - -- - - - - - - -- - - - - - -- - - -- - - -- - -- -- - - - -

ii. Who will obtain consent ? PI/Co-PI Nurse/Counsellor Research staff Any other

9. Will any advertising be done for recruitment of Subjects ? (posters, flyers, brochure, websites – if so kindly attach a copy)

Yes No√

10. Risks & Benefits: i. Is the risk reasonable compared to the anticipated benefits to subjects / community / country?

Yes√

No

ii. Is there physical / social / psychological risk / discomfort? If Yes, Minimal or no risk More than minimum risk High risk

Yes No√

Iii.Is there a benefit a) to the subject ?

Direct Indirect b) Benefit to society

Page 6 of 52

Page 7: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

11. Data Monitoring i. Is there a data & safety monitoring committee/ Board

(DSMB)?

Yes No√

ii. Is there a plan for reporting of adverse events ?If Yes, reporting is done to :

Sponsor Ethics Committee DSMB

Yes√ No

iii. Is there a plan for interim analysis of data? Yes No√

vi. Are there plans for storage and maintenance of all trial database? If Yes, for how long ?

Yes √

5 years

No

12. Is there compensation for participation? If Yes, Monetary In kind Specify amount and type:

Yes No√

13. Is there compensation for injury? If Yes, by Sponsor by Investigator by Insurance by any other company

Yes No√

14. Do you have conflict of interest? (financial/nonfinancial) If Yes, specify :

Yes No√

Page 7 of 52

Page 8: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Checklist for attached documents:

1. Project proposal (IRB form) – in 10 Copies#

2. Curriculum Vitae of all the Investigators 3. Brief description of proposal 4. Patient information sheet * in vernacular language & in English 5. Informed Consent form ** in vernacular language & in English 6. Investigator’s brochure for recruiting subjects 7. Copy of advertisements / Information brochures, if any. 8. Copy of clinical trial protocol and / or questionnaire 9. Case Record Form 10. Attendance sheet of departmental scientific meeting with ppt. 11. If any HMSC/DCGI/DBT/BARC clearance if obtained 12. Investigator’s undertaking 13. Copy of Insurence Policy obtained for the present research work14. Agreements between PI and Sponsor

# Submit one soft copy of above check listed documents to [email protected] with copy [email protected] * Dardi Mahiti Patrak ** Dardi Sahmati Pratrak

Note: 1) Everytime as per the sugessions from the respected IRB members, we update the IRB proforma. So, ask your younger collegues, collegues and other staff members to use the updated proposal form and procure it from Dept. Of Pharmacology, Govt. Medical College, Bhavngar for submission for next IRB meeting. 2) Please maintain one copy of all your IRB documents for your reference.

Date: Name, Signature & Designation of PI

FOR FURTHER COMMUNICATION AND SUBMISSION OF FILLED IN FORM KINDLY CONTACT: Secretary IRB, Prof. & Head, Department of Pharmacology

Page 8 of 52

Page 9: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Investigator's declarationDepartment of Ophthalmology,

Government Medical College & Sir Takhatsinhji General Hospital Bhavnagar-364001 For the research proposal entitled (In Times New Roman fonts, size: 12, capital letters) TO STUDY THE USE OF BOTULINUM TOXIN IN OPHTHALMIC PLASTIC DISORDERS. ___________________________________________________________________________

1. We certify that, we have determined that the proposal herein is not unnecessarily duplicative of previously reported research.

2. We certify that, we are qualified and have enough experience to do such a study /and do the study under guidance of my P.G. guide .

3. For procedures listed under proposal, we certify that we have reviewed the pertinent scientific literature and have found no valid alternative to any procedure described herein which may cause less pain or distress to the patient.

4. We certified that, study will be initiated only upon review and approval of scientific intent by IRB, Govt. Medical College, Bhavnagar and getting a certificate from IRB.

5. We will do necessary changes in our study protocol as per the suggestions given by respected IRB members during meeting before getting approval letter and bound to submit the changes to IRB. We will obtain approval from the IRB, Govt. Medical College, Bhavnagar, before making any significant changes in this study. Institutional Biosafety Committee's (IBC) certification of review and concurrence will be taken (Required for studies utilizing DNA agents of human pathogens).

6. We will do our study according to ICH-GCP guidelines and maintain all the study related records. Whenever asked, we are bound to produce to IRB, Govt. Medical College, Bhavnagar.

7. We will report adverse drug reaction to Pharmacovigilance Cell & IRB whenever, we come across the adverse drug reaction while doing research work. (If Applicable)

8. We certify that, we will follow the recommendations of IRB and Govt. of Gujarat rules and regulation issued from time to time.

9. We certify that, record of all premature termination of a study with a summary of the reasons / final report after completion of the study including microfilms, CDs and Video recordings, will submit to the IRB, Govt. Medical College, Bhavnagar.

Page 9 of 52

Page 10: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

10. At the time of submission of dissertation to Bhavnagar University, Bhavnagar, we will also submit (If applicable- for PG students only) our work to any indexed journal and as a proof copy will be submitted to the IRB office, Dept. of Pharmacology, Govt. Medical College, Bhavnagar.

11. We will also submit the detailed summary of our work in two copies to IRB office after completing the work.

Signature & Name of

1. ---------------------- 2. -------------------- 3. ----------------------

______________ _____________ ______________ Principal Investigator P.G. Guide Professor and Head, Dept. of _____________ Dept. of _____________ Dept. of _____________ (If applicable) (If applicable) Date: . . . . . . . . . Place: Bhavnagar - 364001

Page 10 of 52

Page 11: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Curriculum vitae

1. Name : Dr Yogesh Parmar 2. Designation: 2nd year resident in Ophthalmology Department, Sir Takhtasinhji

General hospital , Bhavnagar.

3. Complete Postal Addresses & PIN:13 / A , Shree Ram Nagar , Sussain – Tarsali Ring Road , Tarsali , Baroda –

390010.

Address : Room no. 401 , Dhanvantary P.G. Hostel , Sir – T hospital , Bhavnagar - 364001 Telephone Number : 9099971818 (M)

Fax : Nil

E-mail : [email protected]

4. Date of birth : 04 / 06 / 1985.

5. Educational Qualification:

Degree Institution Field(s)Year M.B.B.S Government Medical

College, Bhavnagar 2009

Date of Internship completion : 10 / 08 / 2009

Registration number with date : U.G. – G - 42419 ( 11 / 09 / 2009 ) P.G. - not applicable

Page 11 of 52

Page 12: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Registration no. of PG at University: PG / 2010 / 802007 . ( 03 / 08 / 2010 ) 6. Research/Training Experience:

Duration Institution Particulars of work doneResidency (2010-11) training program

Government Medical College, Bhavnagar

Teaching ,Patient management, Emergency services ,Case presentation & surgical hands on experience of various surgeries (Small Incision cataract surgeries, Pterygius Excision with Limbal Stem cell grafting , Trabeculectomy ( Anti Glaucoma Surgeries) , Dacryocystorhinostomy, Conventional as well as Laser DCR Surgery , Eviceration and Eneucleation.

7. Life membership of Subjects professional bodies: Life time membership in All India Ophthalmological Socoiety.

8. Research specialization (major scientific fields of interest): N.A. 9. Recent publications , Poster Presentations :1)Poster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011.

a) Sebaceous gland carcinoma b) A case unilateral papillitis c) CRAO with unusual outcomes

2)Paper presentation in 39th AGOS conference ,Gandhinagar , 2011 - To study the effect of Inj. Bevacizumab in patients of Diabetic Retinopathy .

Books : N.A. Research: N.A. 10. Financial support received: NIL

Signature and Date

Page 12 of 52

Page 13: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Curriculum vitae

1. Name : Dr. Nilesh Parekh 2. Designation: Professor & Head of Ophthalmology Department ,

Sir Takhtasinhji General hospital , Bhavnagar.

3. Complete Postal Addresses & PIN: 22,”Vinay”, Behind central salt, Opposite new filter tank, Bhavnagar - 364002 INDIA .

Address : 22,”Vinay”, Behind central salt, Opposite new filter tank, Bhavnagar - 364002 INDIA.

Telephone Number : +91-278-2566388 (R) 9825252673 (M) Fax : nil

E-mail : [email protected]

4. Date of birth: 13 February, 1966.

5. Educational Qualification:

Degree Institution Field(s)Year

1 )M.B.B.S.B.J.Medical College,Ahmedabad ,INDIA.

From August 1983 to August 1988

2 ) M.S. (OPHTHALMOLOGY)

M & J Institute of Ophthalmology,Civil Hospital, Ahmedabad 380016 , INDIA

2 Sep 1989 TO 31 Oct 1992

Date of Internship completion : August 1989.

Registration number with date : U.G. : G -17752. ( 20/09/1989 ).

Page 13 of 52

Page 14: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

P.G. G – 5183. ( 22/05/1992 ).

Registration no. of PG at University: Not applicable

6. Experience:

Duration Institution Particulars of work done

1 )1 Nov 1992 30 Apr 1994

Shantilal Shah Hospital,Bhavnagar 364001 INDIA

Full time Ophthalmologist

2 ) 1 May 1994 2 Jan 1997

Bajrangdas Bapa Hospital,Bhavnagar 364001 INDIA

Full time Ophthalmologist

3 ) 3 Jan 1997 31 Mar 2002

Government Medical College, Bhavnagar 364001 INDIA

Assistant Professor in Ophthalmology

4 ) 1 April 2002 2 Nov 2006

Government Medical College, Bhavnagar 364001 INDIA

Associate Professor in Ophthalmology

7. Life membership of Subjects professional bodies:

- All India Ophthalmological Society (life member) P-5684

- Gujarat Ophthalmological Society (life member) No 484

- Bhavnagar Ophthalmological Society (life member)

- Indian Medical Association (life member)

- Licensure: Gujarat Medical Council

8. Research specialization :

Page 14 of 52

Page 15: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

*A study of limbal stem cell transplant with conjunctival autografting to prevent recurrence after pterigium surgery

*A study of incidence of CME after uneventful cataract surgery

*Acomparative study of effectiveness of Laser DCR vs Conventional DCR surgery.

*A study of efficacy and safety of Timolol maleate 0.5% eye drops administered once daily vs twice daily in cases of Open angle glaucoma and ocular hypertension.

Positions of honour:

*Executive Secretory ,39th All Gujarat Ophthalmological Society Conference,2011.

*Organising Secretary,37th All Gujarat Ophthalmological Society Conference,2009.

*Programme officer, National Programme for Control of blindness since Jan 1997.

*President, Bhavnagar Ophthalmological Society, 2006-07

*Vice president ,Gujarat Ophthalmological Society, 2004-05 and 2008-09

*Member, Executive committee , Gujarat Ophthalmological Society, 2003-04

Academic Update: Attended a number of conferences/workshops/CMEs regularly and actively participated in it.

Dissertation: A study of change in refractive error after strabismus surgery.

9. Recent publications :

Research:

Page 15 of 52

Page 16: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

1 ) Sturge-Weber syndrome a case report in Gujarat Medical Journal, March 2007

2 ) Clinical features and management of chemical injuries to the eye in Ocular news and views 2005.

3)A study of efficacy & safety of fixed dose combination of latanaprost 0.005% & timolol 0.5% ophthalmic solution ( sunfarma advanced research company limited ) in patient with open angle glaucoma or ocular htn : A randomized open label parallel group active controlled study.

Poster presentation:

1 ) Goldenhare syndrome a case report at Annual Gujarat Ophthalmological conference in 2008,Vadodara

2 ) Cornella De Lange syndrome, a case report at Annual Gujarat Ophthalmological conference in 2006,Ahmedabad

3 ) Sturge Weber syndrome, a case report at Annual Gujarat Ophthalmological conference in 2006,Ahmedabad

4 ) Homocystinuria a case report at Annual Gujarat Ophthalmological conference in 2006,Ahmedabad.

5 ) Bardet Biedl syndrome a case report at Annual Gujarat Ophthalmological conference in 2005 at Junagadh .

6) Poster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011.

d) Sebaceous gland carcinoma e) A case unilateral papillitis f) CRAO with unusual outcomes

Paper presentations:

Page 16 of 52

Page 17: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

1 ) A novel moist chamber in cases of severe proptosis at Annual Gujarat state Ophthalmology conference,Surat ,1992.

2 ) A study of efficacy and safety of Timolol maleate 0.5% eye drops administered once daily vs twice daily in cases of Open angle glaucoma and ocular hypertension. 42nd Annual conference of Indian Pharmacological Society, Kolkata,2009 (adjudged 2nd best paper).

3) Free paper at Annual All India Ophthalmological Conference, ahmedabad 2011 - Comparative study between Conventional Dacryocystorhinostomy and Laser Dacryocystorhinostomy.

4)Paper presentation in AGOS conference , 2011 - To study the effect of Inj. Bevacizumab in patients of Diabetic Retinopathy.

5) Accepted E - Poster in Annual All India Ophthalmological Conference, kochi , 2011 - Comparative study of efficacy of IVTA given during cataract surgery in patients of CSME of diabetic origin & in patients where IVTA was deferred for 3 weeks.

10. Financial support received: Nil

Signature and Date

Curriculum Vitae

Page 17 of 52

Page 18: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

1. Name : Dr. Neepa Gohil 2. Designation: Assistant Professor in Ophthalmology Department ,

Sir Takhtasinhji General hospital , Bhavnagar.

3. Complete Postal Addresses & PIN:

Address : “YASHANSHU”, Plot No.83/A, Chitranjan chowk, Vidhyanagar.Bhavnagar.364002, INDIA.

Telephone Number : 0278(2514180) ( R )

9909978072 ( M ) Fax : nil

E-mail : [email protected]. Date of birth: :4 November,1967

5. Educational Qualification:

Degree Institution Field(s)Year1 ) M.B.B.S: Gujarat University, ndia 1990

2 ) D.O.M.S. Gujarat University,India April 19923 ) M.S. (OPHTHALMOLOGY)

Gujarat University,India April 93

Date of Internship completion : July, 90.Registration number with date U.G. - G-18716. ( 22/08/1990 ).

D.O.M.S:-G-5409. ( 30/11/1992 ). P.G : G-5560. ( 15/05/1993 ).

Registration no. of PG at University: Not applicable

6. Research/Training Experience:

Page 18 of 52

Page 19: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Duration Institution Particulars of work done

1 ) From Oct 93 to Sept 95

Shantilal Shah Hospital Full time ophthalmologist

2 ) From Oct 95 to Aug 2006

Yash Hospital, Bhavnagar

Full time ophthalmologist

3 ) since 5 August 2006 Government Medical College , Bhavnagar.

Assistant Professor

-Academic Update: Attended conferences, workshops, CME regularly and actively participated in it .-Dissertation: A Study of IOP after using visco elastic substances in various Intraocular surgeries.

7. Life membership of Subjects professional bodies:

- All India Ophthalmological Society (life membership) -Gujarat Ophthalmological Society (life membership) - Bhavnagar Ophthalmological society (life membership) - Indian Medical Association (life membership)

8. Research specialization : - General Ophthalmology, Anterior segment, Medical Retina, has performed thousands of cataract surgeries, various anterior segment surgeries. 9. Recent publications :Capillary haemangioma case report in GSB IMA journal ,

April ,2011

10. Presentation: 1) Paper presentation in 39th AGOS conference , Gandhinagar , 2011 - To study the effect of Inj. Bevacizumab in patients of Diabetic

Retinopathy.

2) ) Accepted E - Poster in Annual All India Ophthalmological Conference, kochi , 2012 - Comparative study of efficacy of IVTA given during cataract surgery in patients of CSME of diabetic origin & in patients where IVTA was deferred for 3 weeks.3) Poster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011.

Page 19 of 52

Page 20: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

a) Sebaceous gland carcinoma b) A case unilateral papillitis c) CRAO with unusual outcomes

11. Financial support received: Nil

Signature and Date

Curriculum vitae

Page 20 of 52

Page 21: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

1. Name : Dr Hetal J Patel 2. Designation: 2nd year resident in Ophthalmology Department, Sir Takhtasinhji General hospital , Bhavnagar.

3. Complete Postal Addresses & PIN: Sonadarshan Society, Block No. 31-A, Behind zarna park, Abrama,

Valsad. 396001

Address : Room no. 504 , Dhanvantary P.G. Hostel , Sir Takhtasinhji General hospital , Bhavnagar - 364001

Telephone Number : 9099987070 (M)

Fax : Nil

E-mail : drhetalpatel @ymail.com

4. Date of birth : 5th August, 1986 .

5. Educational Qualification:

Degree Institution Field(s)Year M.B.B.S Government Medical

College, Bhavnagar 2009

Date of Internship completion : 24/03/2010

Registration number with date : U.G. – G - G-43010 . ( 31/03/2010 ) P.G. - not applicable

Registration no. of PG at University: PG / 2010 / 802008 . ( 03 / 08 / 2010 )

6. Research/Training Experience:

Page 21 of 52

Page 22: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Duration Institution Particulars of work doneResidency (2010-11) training program

Government Medical College, Bhavnagar

Teaching ,Patient management, Emergency services ,Case presentation & surgical hands on experience of various surgeries (Small Incision cataract surgeries, Pterygius Excision with Limbal Stem cell grafting , Trabeculectomy ( Anti Glaucoma Surgeries) , Dacryocystorhinostomy, Conventional as well as Laser DCR Surgery , Eviceration and Eneucleation.

7. Life membership of Subjects professional bodies: Life time membership in All India Ophthalmological Society. Provisional membership no- p13880.

8. Research specialization (major scientific fields of interest): N.A.

9. Recent publications (last 5 years, with: titles and references), also Papers in press: N.A.

Books : N.A.

Research: N.A.

10. Financial support received: NIL

Signature and Date

DEPARTMENT OF OPHTHALMOLOGY

GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR-364001

GUJARAT-INDIA

Page 22 of 52

Page 23: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

DESCRIPTION OF PROPOSAL

TITLE – TO STUDY THE USE OF BOTULINUM TOXIN IN OPHTHALMIC

PLASTIC DISORDERS.

INTRODUCTION:

Botulinum toxin is a protein which is most frequently used medications in

ophthalmic plastic surgery. It is produced by the Clostridium Botulinum , Gram

positive bacterium. The organism Clostridium Botulinum  was originally isolated

by Professor E Van Ermengem in 1895. Type A is the most potent toxin,

followed by types B and F toxin.All botulinum neurotoxins are produced as

relatively inactive, single polypeptide chains of about 150 kDa weight with a high

degree of amino acid sequence homology among the toxin .

Mechanism of action :

Botulinum toxins act at four different sites in the body: the neuromuscular

junction, autonomic ganglia, postganglionic parasympathetic nerve endings and

postganglionic sympathetic nerve endings that release acetylcholine (Ach).

Intramuscular administration of botulinum toxin acts at the neuromuscular junction

to cause muscle paralysis by inhibiting the release of Ach from presynaptic motor

neurons .

Benign Essential Blepharospasm :

BEB is an involuntary and repetitive bilateral spasmodic contraction of the

Page 23 of 52

Page 24: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

orbicularis oculi muscle , and is often progressive. It usually presents

in the fourth to sixth decade with an increase in the blink rate, which increases

in 1 or 2 years to forceful involuntary closure of eyelids.

Treatment with botulinum toxin chemodenervation showing good improvement

from the symptoms.

- Blepharospasm is thought to be due to abnormal functioning of the

basal ganglia which are situated at the base of the brain.

It is still not known that what goes wrong in basal ganglia.It may be there

is some disturbance of various ‘messenger’ chemicals involved in

transmitting information from one nerve to another.In most patients ,

blepharospam develops spontaneously with no known precipitating factor.

Hemi Facial Spasm:

- HFS  is characterised by repetitive unilateral periodic tonic

contractions of ipsilateral facial muscles. It begins in middle age, and is

more common in females. It generally results from mechanical-

vascular compression of the seventh cranial nerve root in the cerebello-

pontine angle. Treatment with botulinum toxin injections are effective in

controlling HFS.

Reflex Blepharospasm :

- Reflex blepharospasm, caused by dry eye or ocular surface pathology

Page 24 of 52

Page 25: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

can mimic BEB. It can be associated with spastic lower eyelid entropion

that in turn induces ocular surface damage, and the vicious cycle

continues. It is typically relieved by instillation of topical anaesthetic.

Botulinum toxin injection helps to break the vicious cycle, by inducing

temporary paralysis of orbicularis oculi.

Lower eyelid senile entropion :

- One of the aetiologies of lower eyelid senile entropion is the overriding

of preseptal orbicularis muscle over pretarsal orbicularis muscle. Several

reports have shown the effectiveness of botulinum toxin injection into the

lower orbicularis muscle for temporary control of lower eyelid entropion.

Surgical treatment of senile lower eyelid entropion is definitive and

persistent. However, botulinum toxin chemodenervation is a quick

outpatient procedure  for patients who are unfit or waiting for surgery. The

mean duration of action has been reported to range from 12 to 15 weeks, and

toxin therapy had no adverse effects on results of surgical entropion repair.

Chemo-tarsorrhaphy

- Traditionally, tarsorrhaphy has been used in cases of corneal exposure

due to facial nerve palsy, persistent epithelial defects, and indolent corneal

ulcers. Botulinum toxin chemodenervation of levator muscle is a quick and

easy procedure for induction of temporary ptosis for corneal

Page 25 of 52

Page 26: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

protection, thereby avoiding surgical tarsorrhaphy and subsequent scarring

of eyelid margin.

Aims and objectives:

To study the use of botulinum toxin in patients with Blepharospasm .

To assess the improvement in the symptoms of blepharospasm after

injection on basis of blinking rate/minute & subjective improvement scoring

system.

To know the etiology and to assess the demographic parameters in patient

of blepharospasm.

Justification for Study :

To assess the use of botulinum toxin in blepharospasm.

The use of botulinum toxins has revolutionised the treatment of various

ophthalmic plastic disorders. This is a toxin produced by the

bacteria Clostridium botulinum. It weakens the muscles by blocking nerve

impulses transmitted from the nerve endings of the muscles.

The use of botulinum toxin is quit safe to treat the blepharospasm rather

than going for surgical management (protractor myectomy).

Methodology:

No. of patients included in the study-25

Page 26 of 52

Page 27: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Written informed consent of patient will be taken prior to take the patient for study.

No. of follow-ups - Post-operative 3rd day, 7th day, 1st month , 3rd & 4th month.

Parameters to be checked on Every visit: 1) Blinking Rate / Minute &

2) Subjective Improvement Scoring System.

Duration of study-1 year.

Adverse drug reaction will be notify to the ethical committee.

Source of botulinum toxin – Inj. Neuronox from Ranbaxy.

Cost of amniotic membrane-Rs 8000 per 100 units.

Estimated cost of the study-Rs 65,000/-

Presevation of botulinum toxin – The vial in the refrigerator to be used within

1week to 6 week after reconstitution.

Inclusion Criteria:

1) Benign Essential Blepharospasm

2) Hemi Facial Spasm

3) Reflex Blepharospasm

4) Lower eyelid senile entropion.

5)Chemo-tarsorraphy.

a)For corneal exposure in temporal VII nerve palsy.

b)Indolent corneal corneal ulcers epithelial defects.

Page 27 of 52

Page 28: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

6)Upper eyelid retraction.

7) Aberrant regeration of VIIth nerve.

8)Blinking Rate more than 16/minute will be included in the study.

Exclusion criteria:

1) Peripheral motor neuropathic disease.

2) Neuromuscular junction disorders.

- Myasthenia gravis.

- Eaton-Lambert syndrome.

3) Pregnancy.

4) Areas of active infection.

5) Known hypersensitivity to any ingredient in the formulation.

Technique:

The type A toxin has to be reconstituted with sterile, nonpreserved 0.9% saline

prior to injection . The toxin concentration per 0.1 ml of diluent is dependent on

the volume of diluent used . The reconstituted solution should be clear, colourless

and free of particulate matter, and should be stored in a refrigerator at 40C until

use. The dose recommendations for common therapeutic indications of botulinum

toxin are given in . The reconstituted toxin is drawn into a tuberculin syringe via a

fine gauge needle (30G) for final injection. Botulinum toxin commonly use by

diluting 100 U vial to obtain a dilution of 2.5 or 5 U per 0.1 ml.subcutaneous

Page 28 of 52

Page 29: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

injection of botulinum toxin is given into the orbicularis oculi of upper and lower

eyelids as well as the eyebrows . The sites injected vary for each patient and

subsequent injections are modified based on patient's response to treatment. The

Botulinum toxin to be used within 4 hours of reconstitution, and earlier reports

have mentioned about deterioration of the toxin within few hours after

reconstitution. The fragile toxin molecules are susceptible to damage by

mechanical stress, hence it would be prudent to avoid rapid injection and frothing

during reconstitution. A recent report however has demonstrated no adverse effect

of frothing on the toxin action or duration.

Complications:

1)Upper eyelid ptosis.

2)Lagophthalmos.

3)Ectropion or entropion of the eyelid.

4)Functional epiphora due to lachrymal pump failure.

5)Diplopia.

6)Eyelid haematoma.

Outcome Measures:

Follow up of patient will be done on 3rd day, 7th day , 1st month , 3rd month ,

4th month.

Statistical Analysis

Page 29 of 52

Page 30: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

To assess the percentage of improvement in blepharospasm on basis of

subjective improvement scoring system.

Data analysis will be done on basis of decrease in blinking rate and

subjective assessment of improvement in symptom.

Pre operative & post operative videography of patient done to measure

blinking rate.

Blinking rate per minute will be compared by using paired T – test.

SIGNIFICANCE:

Blepharos

pasm

Pre

injection

Post

injection

3rd day

Post

injection

7th day

Post

injection

1st month

Post

injection

3rd month

Post

injection

4th month

Page 30 of 52

Page 31: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Blinking

rate/minute

Spasms/minutes

Palpebral

fissure height

Patient Satisfaction post injection:

-Subjective Improvement Scoring System:

POOR

AVERAGE

GOOD

EXCELLENT

Page 31 of 52

Page 32: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Page 32 of 52

Page 33: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Page 33 of 52

Page 34: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Page 34 of 52

Page 35: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Page 35 of 52

Page 36: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Page 36 of 52

Page 37: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Page 37 of 52

Page 38: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

VF\B lJEFU

;ZSFZL D[0LS, SM,[H4 EFJGUZP

NNL" DFCLTL 5+S

VeIF; lJUTo a,[OZM:5FhDGF NNL"VMDF\ AM8I],LGD 8MS;LGGL V;ZGM VeIF; SZJMP

l5|I NNL"45|:TFJGFov

TALA[ TDG[ VF VeIF;DF\ EFU ,[JFG] SCI] SFZ6 S[4 TDG[ a,[OZM:5FhD GFDGL VF\BGL 5F\56 OO0JFGL ALDFZL K[PVF ALDFZLDF\ AM8I],LGD 8MS;LG GFDGL NJFYL ;]WFZM YTM CMJFG] ;FALT YI[, K[PT[DH VF NJFGL VF0V;Z 56 VMKL K[P

NJFVM lJQF[ DFCLTLov

AM8I],LGD 8MS;LG GFDGL NJF S,M:8=L0LID AM8I],LGD GFDGF A[S8[ZLIFDF\YL AG[ K[P VF NJF Z[GA[S;L S\5GL AGFJ[ K[PH[ gI]ZMGMS; GFDYL D/[ K[P

Page 38 of 52

Page 39: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

TALAL VeIF; 5wWlTov

VF VeIF;DF\ S], Z5 NNL"VMG[ ;FD[, SZJFDF\ VFJX[ S[ H[DG[ a,[OZM:5FhDGL ALDFZL CX[. TD[ VF VeIF;DF\ EFU ,. XSXM S[ GCL T[ 5|FYlDS TALAL T5F;YL GSSL YX[4 H[ NNL"VM VF VeIF;DF\ EFU ,[JF ;1FD K[ T[J] H6FX[ T[ NNL"VMG[ tIFZAFN AM8I],LGD 8MS;LG GFDGL NJF VF5JFDF\ VFJX[P VF VeIF; NZdIFG NNL" NFSTZGL ZHF l;JFI SM. JWFZFGL NJF ,. XSX[ GCLP

VeIF;DF\ EFU ,LW[, jIlST DF8[ NJFGL DF+Fov

NNL"VMG[ ZP5 I]GL8 5|lT .gH[SXG 5|DF6[ Z5 YL 5_ I]GL8 VF\BGL 5F\56 TYF VF;5F;GF lJ:TFZGF :GFI]DF\ VF5JFGL ZC[X[P

VgI NJFov

VF VeIF; NZdIFG NNL" NFSTZGL ZHF l;JFI SM. JWFZFGL NJF ,. XSX[ GCLPVF TASSF NZdIFG VeIF;DF\ V5FTL NJF l;JFIGL SM. VgI NJF ,[JFGL TDFZ[ H~Z CX[ TM TDG[ VeIF;DF\ RF,] ZFBJF S[ GCL T[ GSSL SZJFGM CS T[GF 5|D]B ;\XMWS 5F;[ ZC[X[P

K]8F YJF AFAT[ov

TD[ VeIF;DF\ :J[lrKS ZLT[ EFU ,. ZCIF KM DF8[ TD[ VeIF; NZdIFG UD[ tIFZ[ K]8F YJF .rKTF CMI tIFZ[ Y. XSM KMPH[GL TDFZL TALAL ;FZJFZ 5Z SM. V;Z YX[ GCL VG[ TDFZF TALAL TDG[ J{Sl<5S p5RFZ 5]Z] 5F0X[P HIFZ[ TALAG[ HF6 YX[ S[ p5ZMST ;FZJFZ TDFZF DF8[ OFINFSFZ GYL VYJF TD[ T[D6[ VF5[,F ;]RG VG];FZ VeIF;GL 5wWlTG] 5F,G GYL SZL ZCIF TM TALA TDG[ VeIF;DF\YL K]8F SZL XSX[P p5ZMST SM. 56 ;\HMUM VG];FZ TDFZL TALAL ;FZJFZ 5Z SM. V;Z YX[ GCL VG[ TDFZF TALA TDG[ J{Sl<5S p5RFZ 5]ZM 5F0TF ZC[X[P

GJL TtSF/ DFCLTLov

TDFZF VeIF;DF\ EFU ,[JFGL ;FY[;\S/FI[,L GJL DFCLTL HF6JF D/X[ TM T[GL TDG[ T]Z\T HF6 SZJFDF\ VFJX[P

Page 39 of 52

Page 40: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

VeIF; NZdIFG TDFZL HJFANFZLVMov

TDFZ[ TALAGF ;]RGMG] 5F,G SZJFG] ZC[X[ VG[ TDG[ H6FjIF VG];FZ NJF ,[JFGL ZC[X[PTDFZ[ VeIF; NZdIFG TDG[ VG]EJFTL SM. 56 5|SFZGL V;]lJWF S[ BZFA VG]EJ TALAG[ H6FJJFGF ZC[X[P HM TD[ :+L NNL" CMJ TM TDFZ[ VeIF; NZdIFG S[ VeIF; 5]6" YIFGF #_ lNJ; NZdIFG UE" WFZ6 SZJM GCLP GJL DFCLTLGF p5IMU AFATov

VF VeIF; £FZF H[ 5lZ6FD D/X[ T[GM p5IMU GJL DFCLTL TZLS[ KF5JF S[ J{7FlGS XMWMG[ ,UTL ;EFVMDF\ NXF"JJF DF8[ YX[PHM TDG[ TDFZL ;FZJFZG[ ,UTM SM. 56 5|`G CMI TM TD[ SM. 56 ;DI[ TDFZF TALA GM ;\5S" ;FWL XSM KMP TD[ HIFZ[ VeIF;DF\ EFU ,. ZCIF CXM V[ NZdIFG TDFZF :JF:yI G[ ,UTL SM. 56 DFCLTL TDFZF TALA G[ D/X[ TM T[VM TDG[ T[GL HF6 SZX[P

;CL VG[ TFZLB5|D]B ;\XMWGSTF"G] GFDo 0M

IMU[X 5L 5ZDFZ;ZGFD]ov WGJ\TZL 5LPHLP CM:8[,vZ 4 ~D G\ $_!

EFJGUZPDMPG\ov )_)))*!(!(.vD[., ov [email protected]

Department of Ophthalmology

Government Medical College , Bhavnagar- 364001, Gujarat .

Patient Information Sheet

Study Detail: To study the use of botulinum toxin in Ophthalmic Plastic Disorder.

Page 40 of 52

Page 41: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Dear Patient,

Introduction:Doctor has told to participate in the study because you are suffering from blepharospasm named blinking disorder.It has been that botulinum toxin is effective in treatment of this disease , as well as side effect of this medicine is less.

Drug Information:Botulinum toxin named medicine is made from the bacteria named clostridium botulinum.this medicine is manufactured by Ranbaxy company , which is available as ‘Neuronox’.

Study Method:In this study total 25 patients will be recruited who is suffering from blepharospasm. If you will participate or not that will be decided by primary medical check up. The patients who are eligible to participate in this study will be given botulinum toxin injection. During this study the patient will not be allowed to take any other medicine without doctor’s permission.

Dose of the drug for patients participating in the study:Patients will be given approx. 2.5 units/injection site , total 25 to 50 units in eyelids and surrounding areas muscles.

Other Drugs:During this study patient cannot take any extra drugs without doctor’s permission. During this study if you will require any drug other than study drug then principle investigator has a right to decide that you will continue to study or not.

Right to discontinue the study : You are voluntarily taking part in this study and you are absolutely free to leave the study at any moment without giving any reason. Such step will not bring any disincentive to you. If doctor will come to know that the following drugs is not going to beneficial for you or you are not following the study method properly then doctor can free you from study. According to above any

Page 41 of 52

Page 42: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

circumstances, you will not compromise to your medical treatment and your doctor will provide alternative treatment to you.

New Information : New information concerned with your taking part in study will be instantly informed to you.

Responsibility of subject : You are bound to obey all the instruction given by doctor and you should co-operate in study whenever required. If you feel any discomfort during study, you have to inform your doctor. If you are female patient, you should not be pregnant during study and after 30 days of completion of study.

Use of result of study : The new information that may be made available by this study may be used for publication or presentation in conferences. If you have any question about your treatment, you can contact to your doctor. If doctor get any information regarding your health while you are participating in the study, doctor will inform you.

Sign and Date :

Investigator’s Name: Dr Yogesh P Parmar.

Address-Dhanvantri P G Hostel,

Room No:401 , Bhavnagar.

Mobile No:9099971818.

Email ID:[email protected]

VF\B lJEFU;ZSFZL D[0LS, SM,[H4

EFJGUZP

NNL" ;\DlT 5+S

Page 42 of 52

Page 43: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

VeIF; lJUTo a,[OZM:5FhDGF NNL"VMDF\ AM8I],LGD 8MS;LGGL V;ZGM VeIF; SZJMP

;CEFULG] 8]\SF1FZL GFDPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP ;CEFULG] GFDo

pDZ ov HFlTov

s!f C]\ ACF, ZFB] K] S[ D[ p5ZMST VeIF; DF8[ TFZLB PPPPPPPPPPPPPPPPPPPPPPP GM SFU/ JF\rIM K[ ò ó VG[ ;DhIM K[ VG[ 5|`GM 5]KJFGL TS DG[ D/L CTLP

sZf C]\ ;DH] K] S[ VeIF;DF\ DFZM ;CEFU DZlHIFT K[ VG[ DFZL TALAL ;\EF/ VYJF SFIN[;Z CSMG] V;Z 5CM\rIF JUZ S\. 56 SFZ6 VF%IF JUZ SM. 56 ;DI[ B;L HJF C]\ D]ST K]P ò ó

s#f C]\ ;DH] K] S[ lRlSt;F,1FL VHDFIXGF\ 5|FIMHSG; JTL SFI" SZTF VgIM GLTLDTF ;lDlT VG[ lGIDSTF" ;TFJF/FVMG[4 C]\ VHDFIXDF\YL B;L HFp\ T[D KTF JT"DFG VeIF; VG[ T[GL ;FY[GF ;\A\WDF\ H[G]\ ;\RF,G SZJFDF VFJ[ T[JF SM. 56 JW] ;\XMWG4 A\G[GL AFATDF\ DFZF VFZMuIGF Z[SM0" HMJF DF8[ 5ZJFGUL HM.X[ GCLP VF 5CM\R V\U[ C]\ ;\DT YFp\ K]P T[D KTF4 C]\ ;DH] K] S[ DFZL VM/B +LHF 51FM DF8[ D]ST SZFI[,L VYKF 5|l;wW SZFI[,L SM.56 DFCLTLDF\ HFC[Z SZJFDF\ VFJX[ GCLP ò ó s$f C]\ ;\DT YFp\ K] S[ VF VeIF; DF\YL H[ p5l:YT YFI T[FJ SM.56 5lZ6FDMGF p5IMU 5Z4 HM T[JM p5IMU OST J{7FlGS C[T] DF8[ CMI TM T[ lGI\+6 SZLX GCLP ò ó

s5f C]\ p5ZGF VeIF;DF\ EFU ,[JF ;\DT YFp K]P ò ó

;CEFULGL ;CL sVYJF V\U]9FG] lGXFGf TFZLBoPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

;CLSTF"G] GFDo PPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

Page 43 of 52

Page 44: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

;CEFULGF SFIN[;Z :JLSFI" 5|lTlGlWGL ;CLovPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP TFZLBoPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

;CL STF"G] GFDo PPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

;\DlT ,[GFZ jIlSTGL ;CL sT5F;STF"qlGI]ST jIlSTfPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

TFZLBo PPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

;CLSTF"G] GFDoPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

;F1FLGL ;CLovPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP TFZLBo PPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

;CLSTF"G] GFDoPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP

;CL VG[ TFZLB

5|D]B ;\XMWGSTF"G] GFDo 0M IMU[X 5L 5ZDFZ;ZGFD]ov WGJ\TZL 5LPHLP CM:8[,vZ 4 ~D G\ $_!

EFJGUZPDMPG\ov )_)))*!(!(.vD[., ov [email protected]

Page 44 of 52

Page 45: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Department of Ophthalmology Government Medical College , Bhavnagar- 364001, Gujarat .

PATIENT CONSENT FORM

Study Detail : To Study The Use Of Botulinum toxin In Ophthalmic Plastic Disorders.

Patient Short Name: Patient Name:

Age : Gender:

1) I accept that I have read the above document for the study dated / / have understood it & have been given the opportunity to ask questions. ò ó

Page 45 of 52

Page 46: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

2) I understand that my contribution to the study is voluntary & I can leave the study at anytime , without affecting my medical assistance or affecting my legal rights, without giving any explanation. ò ó

3) I am aware of the benefits of this study. I have been told about the complications of this procedure . Hence I give my consent for participating in this study after weighing its risk & benefits. ò ó

4) I accept that I will not control the use of any of the evident results arising from the study , if its use is only for scientific purpose. ò ó

5) I accept to join in the above study. ò ó

Patients signature-: Date:

Signaturer’s name-:

Patient’s legally acceptable witness signature Date :

Signaturer’s name-:

Investigaror’s signature: Date:

Signaturer’s Name:

Witness signature-: Date:

Signaturer’s Name:

Page 46 of 52

Page 47: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Sign and Date :

Investigator’s Name: Dr Yogesh P Parmar.

Address-Dhanvantri P G Hostel,

Room No:401 , Bhavnagar.

Mobile No:9099971818.

Email ID:[email protected]

Department of Ophthalmology Sir Takhtasinhji General Hospital, Government Medical College , Bhavnagar- 364001,

Gujarat .

Case Record Form

Name - MRD No. –

Age / Sex - Mobile No. –

Address –

Diagnosis –

History -

Page 47 of 52

Page 48: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Inclusion Criteria:

1) Benign Essential Blepharospasm Yes [ ] No [ ]

2) Hemi Facial Spasm Yes [ ] No [ ]

3) Reflex Blepharospasm Yes [ ] No [ ]

4) Lower eyelid senile entropion Yes [ ] No [ ]

5)Chemo-tarsorraphy.

a)For corneal exposure in temporal VII nerve palsy Yes [ ] No [ ]

b)Indolent corneal corneal ulcers epithelial defects Yes [ ] No [ ]

6)Upper eyelid retraction Yes [ ] No [ ]

7) Aberrant regeration of VIIth nerve. Yes [ ] No [ ]

8)Blinking Rate more than 16/minute will be

included in the study Yes [ ] No [ ]

Exclusion criteria:

1) Peripheral motor neuropathic disease. Yes [ ] No [ ]

2) Neuromuscular junction disorders.

- Myasthenia gravis. Yes [ ] No [ ]

Page 48 of 52

Page 49: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

- Eaton-Lambert syndrome. Yes [ ] No [ ]

3) Pregnancy. Yes [ ] No [ ]

4) Areas of active infection. Yes [ ] No [ ]

5) Known hypersensitivity to any ingredient

in the formulation. Yes [ ] No [ ]

Ocular Examination:-

Right Eye Left Eye

Eyelids

Eyebrows

Conjunctiva

Cornea

Anterior chamber

Iris

Pupil

Lens

BCVA

Ocular position

Ocular Movement

Page 49 of 52

Page 50: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Fundus Examination :

Media

Optic Disc

Macula

Blood vessels

Back ground

Dose Administered: Follow up of the patients following Date of Administration:-

Blepharos

pasm

Pre

injection

Post

injection

3rd day

Post

injection

7th day

Post

injection

1st month

Post

injection

3rd month

Post

injection

4th month

Blinking

rate/minute

Spasms/minute

Palpebral

fissure height

Patient Satisfaction post injection:

Page 50 of 52

Page 51: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

-Subjective Improvement Scoring System:

POOR

AVERAGE

GOOD

EXCELLENT

Department of Ophthalmology

Government Medical College, Bhavnagar (Gujarat) Behind S.T. Stand , Jail Road, Bhavnagar 364001 (Gujarat) India

Phone no (0278) 2430808 Web site: www.bvnmedicol.org Fax no. (0278) 2422011 No. GMCB/Ophthalmology /S. meeting attendance sheet/ ………………….../2011

Date: 28/09/2011Scientific Meeting Attendance Sheet

Scientific Meeting of Department of Ophthalmology, Government Medical College, Bhavnagar was held on 09/09/2011 for the approval of dissertation project of Dr Yogesh P. Parmar entitled “To Study The Use of Botulinum Toxin in Ophthalmic Plastic Disorders”. Dissertation project has been discussed in scientific meeting. Following teaching faculties and postgraduate students were presentName Designation SignatureDr. Nilesh V. Parekh Prof. and HeadDr. Harish R. Trivedi Asso. Prof.Dr. Nipa R. Gohil Asst. Prof.Dr. Priyanka S. Thilak 3rd year residentDr. Nitesh S. Pancholi 3rd year residentDr. Yogesh P. Parmar 2nd year residentDr. Hetal J. Patel 2nd year residentDr. Priyanka G. Bhandare 2nd year resident

Page 51 of 52

Page 52: INDIAN COUNCIL OF MEDICAL RESEARCH - CTRI · Web viewPoster presentation in Annual All Gujarat Ophthalmological Society conference , Gandhinagar , 24th & 25th september , 2011. Sebaceous

Dr. Chintan J. Dedhia 1st year residentDr. Harsh J. Shah 1st year residentDr. Poonam B. Rathod 1st year resident Scientific committee of the department approves the above mentioned dissertation project for consideration to IRB, Govt. medical College, Bhavnagar for approval.

Professor and Head,Department of Ophthalmology,

Government Medical College, Bhavnagar

Page 52 of 52