| CTRI Number |
CTRI/2024/04/065109 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study evaluating the Efficacy of Sub-Tenon Mitomycin C Trabeculectomy with and without Amniotic Membrane Transplantation as an Adjunct
|
|
Scientific Title of Study
|
A Randomised Controlled Trial to Evaluate the Efficacy of Sub-Tenon Mitomycin C Trabeculectomy with and without Amniotic Membrane Transplantation as an Adjunct in a Tertiary Care Centre |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddhant Relekar |
| Designation |
Post Graduate |
| Affiliation |
Shri B .M .Patil Medical College Hospital and Research centre |
| Address |
Ophthalmology department,Shri B .M .Patil Medical College Hospital and Research centre, BANGARAMMA SAJJAN campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9819752116 |
| Fax |
|
| Email |
relekarsid59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Mudhol |
| Designation |
Professor and HoD of Department of Ophthalmology |
| Affiliation |
Shri B .M .Patil Medical College Hospital and Research centre |
| Address |
Shri B .M .Patil Medical College Hospital and Research centre, BANGARAMMA SAJJAN campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9449938997 |
| Fax |
|
| Email |
rekhamudhol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha Mudhol |
| Designation |
Professor and HoD of Department of Ophthalmology |
| Affiliation |
Shri B .M .Patil Medical College Hospital and Research centre |
| Address |
Department of Ophthalmology, Shri B .M .Patil Medical College Hospital and Research centre, BANGARAMMA SAJJAN campus, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9449938997 |
| Fax |
|
| Email |
rekhamudhol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B .M .Patil Medical College Hospital and Research centre |
|
|
Primary Sponsor
|
| Name |
Dr Siddhant Relekar |
| Address |
Shri B .M .Patil Medical College Hospital and Research centre, BANGARAMMA SAJJAN campus, Vijayapura 586103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SIDDHANT RELEKAR |
Shri B .M .Patil Medical College Hospital and Research centre |
Department of Ophthalmology
Bijapur
KARNATAKA |
9819752116
relekarsid59@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri B.M. Patil Medical College,Hospital and Research Centre, VIJAYAPURA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H402||Primary angle-closure glaucoma, (3) ICD-10 Condition: H403||Glaucoma secondary to eye trauma, (4) ICD-10 Condition: H408||Other glaucoma, (5) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TRABECULECTOMY WITH SUB-TENON MITOMYCIN C AND AMNIOTIC MEMBRANE TRANSPLANTATION UNDER LOCAL ANAESTHESIA |
subtenon injection of mitomycin c 0.02% combined with Amniotic membrane placed and sutured above the scleral flap during trabeculectomy
duration of surgery would be around 30 minutes |
| Comparator Agent |
TRABECULECTOMY WITH SUB-TENON MITOMYCIN-C INJECTION UNDER LOCAL ANESTHESIA |
subtenon injection of mitomycin
0.02% during trabeculectomy
duration of surgery would be around 30 min |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients of open-angle glaucoma and angle-closure glaucoma fulfilling the following criteria were included
1.IOP more than 21 mmHg despite using IOP-lowering medications
2.Patients willing for 3-month follow-up and investigations
|
|
| ExclusionCriteria |
| Details |
A history of prior surgical interventions in the form of past glaucoma filtering surgery, cataract surgery, or any other surgery involving conjunctiva, or co-existing conjunctival disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will provide further insight into the efficacy of amniotic membrane transplantation as an adjunct to sub-tenon Mitomycin trabeculectomy |
pre-operative
post operative 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will provide further insight into the efficacy of amniotic membrane transplantation as an adjunct to sub-tenon Mitomycin trabeculectomy |
post operative day 1
post operative day 7 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/04/2024 |
| Date of Study Completion (India) |
25/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomised Controlled Trial evaluating the
efficacy of amniotic membrane transplantation as an adjunct in sub-tenon
MMC-augmented trabeculectomy. in a sample size of 42 eyes. Patients diagnosed with primary open-angle
glaucoma and primary angle closure glaucoma are included and divided into
control and study groups. The control group will undergo trabeculectomy with Sub-tenon
Mitomycin C alone and the study group will undergo trabeculectomy with
Sub-tenon Mitomycin C combined with AMT. The patients will be selected according
to a Computerized Randomisation chart. |