Outcomes and success of amniotic membrane transplantation for the treatment of corneal diseases.
Ozlem Dikmetas, Yasemin Kapucu, Ali Bülent Cankaya...
https://pubmed.ncbi.nlm.nih.gov/37879107Actively Recruiting
Phase 4
Age: 16Years - 70Years
All Genders
Healthy Volunteers
ID07561398
Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea
Led by Al-Shifa Trust Eye Hospital · Updated on 2026-05-01
214
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of two treatments for persistent corneal epithelial defects, a condition where the surface of the eye does not heal properly. The study focuses on patients who have had corneal defects for more than two weeks despite standard treatment. Researchers will assess the healing progress to understand which treatment may better help the eye surface repair itself. Participants will be randomly assigned to one of two groups. One group will receive topical insulin eye drops applied every six hours until the corneal defects fully heal. The other group will undergo a surgical procedure where an amniotic membrane graft is applied to help the cornea recover. This treatment phase will follow an initial standard care period. Over a total of 24 weeks, patients will be regularly monitored with eye examinations and specialized corneal photography to measure the size and healing of the defects. The healing area will be graded and analyzed by a single observer using image analysis software. Researchers will track both the cure rate and the average time to healing. Follow-up visits will ensure careful observation of progress and safety throughout the study.
CONDITIONS
Brief Title
Comparison of Topical Insulin and Amniotic Membrane Transplant for Persistent Corneal Epithelial Defects
Who Can Participate
Age: 16Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Corneal epithelial defects for more than 2 weeks with no improvement using standard treatment
- Age between 16 and 70 years
- All genders are eligible
You will not qualify if you...
- Uncontrolled diabetes or autoimmune disorders
- Recent eye surgery within the last 3 months
- Hereditary corneal dystrophies
- Active eye infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until complete healing of corneal epithelial defects
Participants receive either topical insulin eye drops every 6 hours until the corneal epithelial defects heal, or a surgical amniotic membrane graft to repair the defects.
Follow-up visits up to 24 weeks after treatment start
Follow-up
Duration - Up to 24 weeks
Participants are monitored for healing progress and cure rate up to 24 weeks after treatment initiation.
Regular follow-up visits during the 24-week period
Trial Site Locations
Total: 1 location
1
Al Shifa Eye Trust Hospital
Rawalpindi, Punjab Province, Pakistan, 46000
Actively Recruiting
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Research Team
S
Subha Mashaam Principal Investigator, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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