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

NCT07561398 | Recruiting Phase 4 DMC

• 1 other identifier: ERC-42/AST-24
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistent Corneal Epithelial Defect

Keywords

Topical Insulin; Amniotic Membrane graft

Outcome Measures

Primary Outcomes (1)

• Cure rate

  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 Outcomes (1)

• Mean time to healing

  From time of randomization upto 24th week of followup

Study Arms (2)

Group Topical Insulin

ACTIVE COMPARATOR

Drug: Topical insulin eye drops

Group Amniotic Membrane graft

ACTIVE COMPARATOR

Procedure: Amniotic Membrane Graft

Interventions

Topical insulin eye drops DRUG

Topical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects

Group Topical Insulin

Amniotic Membrane Graft PROCEDURE

Surgically amniotic membrane grafts will be applied to bridge and heal the corneal defects

Group Amniotic Membrane graft

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders
• Recent eye surgery within last 3 months
• Hereditary corneal dystrophies
• Active eye infections

Sponsors & Collaborators

• Al-Shifa Trust Eye Hospital: lead

Study Sites (1)

Al Shifa Eye Trust Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (1)

• Dikmetas O, Kapucu Y, Cankaya AB, Kocabeyoglu S. Outcomes and success of amniotic membrane transplantation for the treatment of corneal diseases. Cutan Ocul Toxicol. 2024 Mar;43(1):33-37. doi: 10.1080/15569527.2023.2275018. Epub 2023 Oct 31.

  PMID: 37879107 BACKGROUND

Study Officials

• Shama Khan, MBBS,FCPS

  Senior Consultant Cornea Department

  STUDY CHAIR

Central Study Contacts

Subha Mashaam Principal Investigator, MBBS

CONTACT

+92-340-6805428; creativedoctor@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: May 1, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): September 27, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)