Early Amniotic Membrane Transplantation in Bacterial Keratitis

NCT02716883 | Unknown

• 1 other identifier: 23345
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Keratitis of Both Eyes

Keywords

keratitis; AMT; bacterial keratitis; medication

Outcome Measures

Primary Outcomes (1)

• Time to scar formation

  The time keratitis needs for scar to be formed

  It needs at most 3 months

Study Arms (2)

Non AMT

NO INTERVENTION

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

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

Interventions

AMT PROCEDURE

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.

AMT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Bacterial keratitis being in the first week of diagnosis medically undergoing treatment

You may not qualify if:

• thinning limbal extension intraocular extension underlying disease Nocardia keratitis

Sponsors & Collaborators

• Farabi Eye Hospital: lead

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: March 23, 2016
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share