Outcome of amniotic membrane transplant versus conjunctival autograft: A comparative study

Phase 2/3

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2024/09/074140
• Lead Sponsor: Dr Ruma Das Debsikdar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-30
• Study Completion: 2024-09-30
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

Pseudopterygium Ocular surface disorders Chemical burns Cicatricial conjunctival disease Severe dry eye Uncontrolled systemic illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity	Post operative days 0, 7, 30, 90, 180

Secondary Outcome Measures

Name	Time	Method
Keratometry values, graft staining

Trial Locations

Locations (1)

Silchar Medical College and Hospital; 🇮🇳 Cachar, ASSAM, India

Silchar Medical College and Hospital

🇮🇳Cachar, ASSAM, India

Dr Ruma Das Debsikdar

Principal investigator

7635801620

d345rumads@gmail.com