Persistent Corneal Epithelial Defect
Conditions
Keywords
Topical Insulin, Amniotic Membrane graft
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.
Interventions
Topical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects
PROCEDUREAmniotic Membrane Graft
Surgically amniotic membrane grafts will be applied to bridge and heal the corneal defects
Sponsors
Al-Shifa Trust Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean time to healing | From time of randomization upto 24th week of followup | 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. |
Countries
Pakistan
Contacts
CONTACTSubha Mashaam Principal Investigator, MBBS
STUDY_CHAIRShama Khan, MBBS,FCPS
Senior Consultant Cornea Department
Outcome results
None listed