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NCT02716883 Clinical Trial

Early Amniotic Membrane Transplantation in Bacterial Keratitis

Keratitis of Both Eyes Clinical Trial

Official title:
Early Amniotic Membrane Transplantation in Bacterial Keratitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02716883
Other study ID # 23345
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 13, 2015
Last updated March 26, 2016
Start date January 2014
Est. completion date April 2016

Study information
Verified date March 2016
Source Farabi Eye Hospital
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 14
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Farabi Eye Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Time to scar formation The time keratitis needs for scar to be formed It needs at most 3 months Yes