| CTRI Number |
CTRI/2025/07/091086 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A trial of newer techniques in eye surgery to prevent recurrence of Pterygium |
|
Scientific Title of Study
|
Evaluation of safety and efficacy of conjunctival autograft with adjuvants in comparison to conjunctival limbal autograft technique- A randomised control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharani Padam |
| Designation |
Assistant professor |
| Affiliation |
ESIC Medical College and hospital, Sanathnagar, Hyderabad |
| Address |
Department of Ophthalmology, ESIC Medical College, Sanathnagar,Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9963692545 |
| Fax |
|
| Email |
dharani.padam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dharani Padam |
| Designation |
Assistant professor |
| Affiliation |
ESIC Medical College and hospital, Sanathnagar, Hyderabad |
| Address |
Department of Ophthalmology, ESIC Medical College, Sanathnagar,Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9963692545 |
| Fax |
|
| Email |
dharani.padam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharani Padam |
| Designation |
Assistant professor |
| Affiliation |
ESIC Medical College and hospital, Sanathnagar, Hyderabad |
| Address |
Department of Ophthalmology, ESIC Medical College, Sanathnagar,Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9963692545 |
| Fax |
|
| Email |
dharani.padam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital, Sanathnagar, Hyderabad |
| Address |
ESIC Medical College and Hospital, Sanathnagar, Hyderabad 500038 |
| Type of Sponsor |
Government 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 Padam Dharani |
Employees State Insurance Corporation Medical College and Hospital |
Room number 7, Third floor, Department of Ophthalmology, OPD Building
Hyderabad
TELANGANA |
9963692545
dharani.padam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College and Hospital and ESIC Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H110||Pterygium of eye, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pterygium excision with conjunctival limbal autograft and without adjuvants |
All 90 patients will undergo Pterygium excision with conjunctival limbal autograft.Of these one third will receive intra operative Mitomycin C and one third will receive pre operative subconjunctival Duration of Pterygium surgery is between 40 to 50 minutes |
| Comparator Agent |
Pterygium excision with conjunctival limbal autograft with Mitomycin C |
Following pterygium excision and conjunctival limbal autograft placement,Mitomycin C (intra operative) will be administered to 30 patients.Duration of surgery is between 40 to 50 minutes. Administration of Mitomycin C takes less than two minutes. |
| Comparator Agent |
Pterygium excision with conjunctival limbal autograft with pre operative subconjunctival Bevacizumab injection |
Prior to pterygium excision and conjunctival limbal autograft placement, subconjunctival Bevacizumab injection will be given preoperative to 30 patients.Duration of surgery is between 40 to 50 minutes.Administration of Bevacizumab takes less than 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 20- 70 years presenting with primary pterygium of any grade |
|
| ExclusionCriteria |
| Details |
Patients allergic to Anesthetic drugs,Antimetabolites and Anti
VEGFs, recurrent pterygium,scleral thinning, Acute inflammatory diseases of the eye,severe dry eye,Pregnancy,Hypertension,Cardiac issues and Coagulopathies,Cranial nerve
palsies involving extra ocular muscles,Glaucoma,patients not willing to participate in the
study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recurrence rates of Pterygium and complications |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Randomised control study conducted over a period of one year including patients aged 20 - 70 years presenting with primary pterygium of any grade. 90 patients will be divided into three groups A B and C by simple randomisation . Group A patients will undergo pterygium excision with conjunctival limbal autograft technique. Group B patients will be treated by pterygium excision with conjunctival autograft and intra operative Mitomycin C. Group C patients will be treated by pterygium excision with conjunctival autograft following pre operative subconjunctival Bevacizumab injection. Patients will be followed up on post operative day one, one week , one month, 3 months, 6 months and one year post surgery. At each follow up patient will be assessed for visual acuity, post surgery complications, including recurrence |