Topical insulin drops vs amniotic membrane graft for persistent corneal epithelial defects
Official title: Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea
Run by Al-Shifa Trust Eye Hospital · NCT07561398 · Data updated 2026-11-12
We will test whether topical insulin eye drops or an amniotic membrane graft better helps heal persistent corneal epithelial defects that have not improved with standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Enrollment | 214 (estimated) |
| Sponsor | Al-Shifa Trust Eye Hospital Academic / other |
| Locations | 1 site (Rawalpindi, Punjab Province) |
| Status | Recruiting |
| Started | March 27, 2026 |
| Main results expected | September 27, 2026 |
| Study ends | September 27, 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07561398 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with corneal epithelial defects persisting for more than two weeks despite standard treatment, who do not have uncontrolled systemic disease and can attend follow-up at the study center.
✕Probably not a fit
Patients with uncontrolled diabetes, autoimmune disorders, recent eye surgery within three months, hereditary corneal dystrophies, active eye infections, or those who heal with standard care are unlikely to benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
After an initial period of standard care, eligible patients with corneal epithelial defects lasting more than two weeks will be randomly assigned to receive either amniotic membrane grafting or topical insulin eye drops given every six hours until the defect heals. Healing will be measured using fluorescein staining with anterior segment photography and quantified by a single observer using ImageJ to calculate defect area and grade severity. Patients will be followed with regular clinic visits for up to 24 weeks to track time to re-epithelialization and any complications. Randomization and standardized imaging aim to provide a direct comparison of the two approaches for defects that have not responded to first-line measures.
Why it matters
Potential benefit: If successful, this could provide a clearer, evidence-based option that speeds corneal surface healing and reduces the risk of vision loss, potentially offering a low-cost topical alternative to surgery.
How similar studies have gone: Amniotic membrane grafting is an established therapy for persistent epithelial defects, while topical insulin has shown promising early results in smaller studies but direct randomized comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Al Shifa Eye Trust Hospital
Rawalpindi, Punjab Province, Pakistan Recruiting
Study contacts
- Study coordinator: Subha Mashaam Principal Investigator, MBBS
- Email: creativedoctor@gmail.com
- Phone: +92-340-6805428
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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TP-06 for Persistent Corneal Epithelial Defects: see if healing improves
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.