A Phase 4 interventional study of Topical insulin eye drops and Amniotic Membrane Graft in Persistent Corneal Epithelial Defect, sponsored by Al-Shifa Trust Eye Hospital. Recruiting at 1 site in Pakistan. Open to participants aged 16 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Al-Shifa Trust Eye Hospital · Phase 4, Interventional, and Treatment
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.
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.
Al-Shifa Trust Eye Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders
Drug: Topical insulin eye drops
Procedure: Amniotic Membrane Graft
Topical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects
Surgically amniotic membrane grafts will be applied to bridge and heal the corneal defects
Cure rate
This will be the number of patients out of total number in each group completely cured of corneal epithelial defects
Time frame: From time of randomization up to 24th week of followup.
Mean time to healing
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.
Time frame: From time of randomization upto 24th week of followup
Plan to share: No — Ethical Committee doesnt allow data sharing
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