Post on 18-Apr-2018
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
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 ID-drscorrpion@gmail.com
Co-PI / Collaborators
1.
Dr Nilesh V Parekh
22 vinay,behind central salt,opp. New filter tank,Bhavnagar .Mo.no – 9825252673.E mail ID - drnvparekh@hotmail.com
2.
Dr Neepa R Gohil ‘YASHANSHU ’ Bunglaw.Plot no.83.Bhavnagar.Mo no.9909978072.Email ID-neepasolanki@hotmail.com
3.
Dr Hetal J Patel Room no.504 ,Dhanvantary PG hostel-2 ,Sir-T Hospital ,Bhavnagar.Mo.no- 9099987070Email ID-drhetalpatel@ymail.com
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
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
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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
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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
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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
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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√
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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 irb_gmcb@yahoo.com with copy tocbrtripathi@yahoo.co.in * 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
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.
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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
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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 : drscorrpion@gmail.com
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
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
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 : drnvparekh@hotmail.com
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
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
*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
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
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
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 : neepasolanki@hotmail.com4. 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
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
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
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
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
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
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
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
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
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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
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
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
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
Blinking
rate/minute
Spasms/minutes
Palpebral
fissure height
Patient Satisfaction post injection:
-Subjective Improvement Scoring System:
POOR
AVERAGE
GOOD
EXCELLENT
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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
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
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:drscorrpion@gmail.com
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Page 44 of 52
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
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
Sign and Date :
Investigator’s Name: Dr Yogesh P Parmar.
Address-Dhanvantri P G Hostel,
Room No:401 , Bhavnagar.
Mobile No:9099971818.
Email ID:drscorrpion@gmail.com
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
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
- 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
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
-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
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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
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