Comparison of Topical Insulin and Amniotic Membrane Transplant for Persistent Corneal Epithelial Defects

April 28, 2026 updated by: Subha Masham, Al-Shifa Trust Eye Hospital

Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea

After an initial period of standard treatment, they received further care aimed at helping the surface of the eye heal. Clear instructions were given on how to use and store the treatment properly. Patients were then monitored regularly over several months, with doctors checking their healing progress during follow-up visits. The study continued for a total of 24 weeks to observe how well and how quickly the eye surface recovered.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The area of the corneal epithelial defects will be evaluated using anterior segment photography of the cornea which will be performed after administration of fluorescein dye at a magnification of 10× using a camera attached to a slit-lamp microscope. The images will be analyzed with an image analysis system (ImageJ software) by a single observer to determine the epithelial defect area. The corneal epithelial defect will be graded from I through III. The patients will be randomly divided into two groups using computer generated random number. One half will be treated with Amniotic membrane grafts while other half will receive treatment with topical insulin drops administered every 6 hours till complete re-epithelization of corneal epithelial defects. Follow up will be done uptil 24 weeks.

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46000
        • Recruiting
        • Al Shifa Eye Trust Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Corneal epithelial defects for more than 2 weeks no improvement using standard treatment

Exclusion Criteria:

  • • Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders

    • Recent eye surgery within last 3 months
    • Hereditary corneal dystrophies
    • Active eye infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Topical Insulin
Drug: Topical insulin eye drops
Topical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects
Active Comparator: Group Amniotic Membrane graft
Procedure: Amniotic Membrane Graft
Surgically amniotic membrane grafts will be applied to bridge and heal the corneal defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate
Time Frame: From time of randomization up to 24th week of followup.
This will be the number of patients out of total number in each group completely cured of corneal epithelial defects
From time of randomization up to 24th week of followup.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean time to healing
Time Frame: From time of randomization upto 24th week of followup
This will be the mean time to complete healing in weeks from initiation of treatment until full epithelial closure as confirmed by lack of fluorescein staining on slit-lamp examination.
From time of randomization upto 24th week of followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Shifa Trust Eye Hospital

Investigators

  • Study Chair: Shama Khan, MBBS,FCPS, Senior Consultant Cornea Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

September 27, 2026

Study Completion (Estimated)

September 27, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERC-42/AST-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethical Committee doesnt allow data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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