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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Topical Insulin | Active Comparator |
| |
| Group Amniotic Membrane graft | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical insulin eye drops | Drug | Topical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate | This will be the number of patients out of total number in each group completely cured of corneal epithelial defects | From time of randomization up to 24th week of followup. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From time of randomization upto 24th week of followup |
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Inclusion Criteria:
Exclusion Criteria:
• Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Subha Mashaam Principal Investigator, MBBS | Contact | +92-340-6805428 | creativedoctor@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shama Khan, MBBS,FCPS | Senior Consultant Cornea Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Shifa Eye Trust Hospital | Recruiting | Rawalpindi | Punjab Province | 46000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37879107 | Background | 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. |
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Ethical Committee doesnt allow data sharing
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| Amniotic Membrane Graft | Procedure | Surgically amniotic membrane grafts will be applied to bridge and heal the corneal defects |
|