Early Amniotic Membrane Transplantation in Bacterial Keratitis

Farabi Eye Hospital

Status: Unknown

Conditions: Keratitis of Both Eyes

Treatments: Procedure: AMT

Study type: Interventional

Funder types: Other

Identifiers

NCT02716883

23345

Details and patient eligibility

About

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

Full description

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)

Enrollment: 14 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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14 participants in 2 patient groups

Non AMT

No Intervention group

Description:

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

AMT

Active Comparator group

Description:

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.

Treatment:

Procedure: AMT