Comparison of Topical Insulin and Amniotic Membrane Transplant for Persistent Corneal Epithelial Defects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical insulin eye drops, Amniotic Membrane Graft.
- Who it may be relevant to
- Registry conditions: Persistent Corneal Epithelial Defect. Basic parameters: 16 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea
Overview
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.
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.
Interventions
- Drug Topical insulin eye drops
Topical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects - Procedure Amniotic Membrane Graft
Surgically amniotic membrane grafts will be applied to bridge and heal the corneal defects
Primary outcome measures
- Cure rate [Time frame: From time of randomization up to 24th week of followup.]
Secondary outcome measures (1)
- Mean time to healing [Time frame: From time of randomization upto 24th week of followup]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Al Shifa Eye Trust Hospital — Rawalpindi
Publications
- 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
Identifiers
NCT: NCT07561398 · ERC-42/AST-24