Early Amniotic Membrane Transplantation in Bacterial Keratitis

March 26, 2016 updated by: mohammad soleimani, Farabi Eye Hospital
In this study Investigators are going to do early amniotic membrane transplantation (AMT) for bacterial keratitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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)

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Non AMT

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

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

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farabi Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2016

Study Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

March 17, 2016

First Posted (ESTIMATE)

March 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 26, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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