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Trial record 6 of 589 for:    "keratitis-ichthyosis-deafness syndrome" OR "Keratitis"

Early Amniotic Membrane Transplantation in Bacterial Keratitis

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ClinicalTrials.gov Identifier: NCT02716883
Recruitment Status : Unknown
Verified March 2016 by mohammad soleimani, Farabi Eye Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
mohammad soleimani, Farabi Eye Hospital

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

Condition or disease Intervention/treatment Phase
Keratitis of Both Eyes Procedure: AMT Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Early Amniotic Membrane Transplantation in Bacterial Keratitis
Study Start Date : January 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Time to scar formation [ Time Frame: It needs at most 3 months ]
    The time keratitis needs for scar to be formed



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Responsible Party: mohammad soleimani, Assistant Professor, Farabi Eye Hospital
ClinicalTrials.gov Identifier: NCT02716883     History of Changes
Other Study ID Numbers: 23345
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by mohammad soleimani, Farabi Eye Hospital:
keratitis
AMT
bacterial keratitis
medication

Additional relevant MeSH terms:
Keratitis
Corneal Diseases
Eye Diseases