| CTRI Number |
CTRI/2024/09/074140 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Outcome of amniotic membrane transplant versus conjunctival autograft: A comparative study
|
|
Scientific Title of Study
|
A comparative study of amniotic membrane graft versus conjunctival autograft following pterygium surgery
|
| 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 Ruma Das Debsikdar |
| Designation |
Professor and Head of the Department, Ophthalmology, Silchar Medical College and Hospital |
| Affiliation |
SILCHAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Ophthalmology, Silchar Medical College and Hospital, Silchar
Cachar
ASSAM
788014
India |
| Phone |
7635801620 |
| Fax |
|
| Email |
d345rumads@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruma Das Debsikdar |
| Designation |
Professor and Head of the Department, Ophthalmology, Silchar Medical College and Hospital |
| Affiliation |
SILCHAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Ophthalmology, Silchar Medical College and Hospital, Silchar
Cachar
ASSAM
788014
India |
| Phone |
7635801620 |
| Fax |
|
| Email |
d345rumads@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Indrayudh Bandyopadhyay |
| Designation |
Junior Resident, Department of Ophthalmology, Silchar Medical College and Hospital |
| Affiliation |
SILCHAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Ophthalmology, Silchar Medical College and Hospital, Silchar
Cachar
ASSAM
788014
India |
| Phone |
09123347916 |
| Fax |
|
| Email |
indrayudh96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silchar Medical College and Hospital, Silchar, Assam, India 788014 |
|
|
Primary Sponsor
|
| Name |
Dr Ruma Das Debsikdar |
| Address |
Professor and Head of the Department, Ophthalmology, Silchar Medical College and Hospital, Silchar, Assam, India 788014 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ruma Das Debsikdar |
Silchar Medical College and Hospital |
Department of Ophthalmology, Silchar Medical College and Hospital, Silchar 788014
Cachar
ASSAM |
7635801620
d345rumads@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Silchar Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic membrane graft |
The amniotic membrane will be obtained from a healthy individual post delivery via Caesarian section duly screened for HIV 1&2, Hepatitis B, Hepatitis C and VDRL. Grafts will be taken and sutured at the site of pterygium excision and the patient will be followed up for 6 months |
| Comparator Agent |
Conjunctival autograft |
A portion of patients own bulbar conjunctiva will be excised from superotemporal region as a graft and will be sutured at the site of pterygium excision and will be followed up for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Patients willing to undergo surgery and ready to give informed consent
All cases and grades of pterygium including
Primary pterygium
Recurrent pterygium
Progressive and Regressive pterygia
Unilateral and Bilateral pterygia |
|
| ExclusionCriteria |
| Details |
Pseudopterygium
Ocular surface disorders
Chemical burns
Cicatricial conjunctival disease
Severe dry eye
Uncontrolled systemic illness. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual acuity |
Post operative days 0, 7, 30, 90, 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Keratometry values, graft staining
|
Post operative days 0, 7, 30, 90, 180 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| Date of Study Completion (India) |
30/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
AIM: To compare the results of amniotic membrane transplantation and conjunctival autograft following pterygium excision STUDY DESIGN: Prospective interventional randomised clinical trial.
STUDY AREA: This study will be carried out at the Department of Ophthalmology, Silchar Medical College and Hospital, Silchar, Assam.
STUDY POPULATION: Those patients with pterygium attending Ophthalmology outpatient department and inpatient department (IPD) at Silchar Medical College and Hospital during the study period and those who fulfil the inclusion and exclusion criteria will be selected.
STUDY PERIOD: 1 year
SAMPLE SIZE: 50 INCLUSION CRITERIA:
• Age > 18 years
• Patients willing to undergo surgery and ready to give informed consent
• All cases and grades of pterygium including
i) Primary pterygium
ii) Recurrent pterygium
iii) Progressive and Regressive pterygia
iv) Unilateral and Bilateral pterygia
EXCLUSION CRITERIA:
• Pseudopterygium
• Ocular surface disorders
• Chemical burns
• Cicatricial conjunctival disease
• Severe dry eye
• Uncontrolled systemic illness.
METHOD OF DATA COLLECTION: All cases of pterygium attending the Eye OPD of Silchar Medical College will be studied. The data will be collected according to the cases including the patient’s particulars, detailed history, clinical examination, preoperative investigations and post-operative findings among the sample population. The entire study will be conducted under the direct guidance and supervision of my guide. A written informed consent will be taken from all patients before the start of my study. The patients will be divided into two equal groups, the first group will be treated with amniotic membrane graft and the rest will be treated with conjunctival autograft
STATISTICAL ANALYSIS: Unpaired t- test will be done for the statistical analysis of my data
ETHICAL CONSIDERATIONS: Study will be initiated after getting approval of institutional ethical committee (IEC) at SMCH.
FINANCIAL COST TO THE SUBJECTS FOR PARTICPATION: None
RESULTS AND OBSERVATION:
The results are to be obtained as per the proforma and to be analysed at the end of the study and the observations will be expressed in appropriate charts and diagrams.
DISCUSSION:
Discussion will be made on the basis of outcome of results and observation of the study.
SUMMARY AND CONCLUSION:
After thorough analysis of data, summary of the whole study will be made and conclusion will be drawn on the outcome of the study.
|