Early Amniotic Membrane Transplantation in Bacterial Keratitis

Study Overview
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Brief Summary
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In this study Investigators are going to do early amniotic membrane transplantation (AMT) for bacterial keratitis.

Detailed Description
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In this study investigators are going to do amniotic membrane transplantation (AMT), early in the first week for bacterial keratitis. Investigators are comparing this technique with no amniotic membrane transplantation (NAMT) in a clinical trial, Inform consent is going to be taken, then the enrolment population is added in the study. Investigators are going to compare the final scar size, the time to scar formation, perforation rate , early need to penetrating keratoplasty (PKP), risk of vision loss (being no light perception (NLP) between two groups.This trial has been approved by the review board in Tehran University of Medical Sciences.( 487/5671)

Official Title
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Early Amniotic Membrane Transplantation in Bacterial Keratitis

Conditions
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Keratitis of Both Eyes

Intervention / Treatment
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* Procedure: AMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bacterial keratitis being in the first week of diagnosis medically undergoing treatment Exclusion Criteria: thinning limbal extension intraocular extension underlying disease Nocardia keratitis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non AMT<br>Freshly prepared fortified eye drops (cefazolin 50 mg/mL and amikacin 14 mg/mL) were applied as starting treatment. In the first 3 days, eye drops are applied round the clock followed by drops every 2 h during waking hours until results of laboratory investigation were available. After preparation of the culture results, the antimicrobial treatment was narrowed according to bacterial sensitivity. Also topical betamethasone 0.1% four times a day on a tapering weekly dosage until 3-4 weeks is used for all patients. If the patient underwent any tectonic procedure during the treatment such as keratoplasty, cyanoacrylate glue are documented | |
| Active Comparator: AMT<br>This group (case group) received above mentioned routine antibiotic therapy followed by double-layer amniotic membrane transplantation 2-5 days after the start of medications and the second group (control group) only received routine antibacterial therapy. The AM was trimmed in two layers to fit the corneal ulcer and was placed with its epithelium (basement membrane) side up, secured with 10/0 nylon sutures, supported by a therapeutic contact lens. If the patient underwent any tectonic procedure during the treatment such as keratoplasty, cyanoacrylate glue are documented. | Procedure: AMT<br>* The AM was trimmed in two layers to fit the corneal ulcer and was placed with its epithelium (basement membrane) side up, secured with 10/0 nylon sutures, supported by a therapeutic contact lens. The operated eye was patched for 2 h, and then administration of the medical treatment agents was resumed. In patients in the case group AMT was performed during days 2-5 of antibiotic therapy when initial clinical response to the treatment was observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to scar formation | The time keratitis needs for scar to be formed | It needs at most 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratitis, AMT, bacterial keratitis, medication