Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Cure rate
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group Topical Insulin
Intervention: Topical insulin eye drops (Drug)
Group Amniotic Membrane graft
Intervention: Amniotic Membrane Graft (Procedure)
Outcomes
Primary Outcomes
Cure rate
Time Frame: From time of randomization up to 24th week of followup.
This will be the number of patients out of total number in each group completely cured of corneal epithelial defects
Secondary Outcomes
- Mean time to healing(From time of randomization upto 24th week of followup)
Investigators
Subha Masham
Principal Investigator
Al-Shifa Trust Eye Hospital