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Early Amniotic Membrane Transplantation in Bacterial Keratitis

Primary Purpose

Keratitis of Both Eyes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AMT
Sponsored by
Farabi Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratitis of Both Eyes focused on measuring keratitis, AMT, bacterial keratitis, medication

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Non AMT

    AMT

    Arm 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

    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.

    Outcomes

    Primary Outcome Measures

    Time to scar formation
    The time keratitis needs for scar to be formed

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2015
    Last Updated
    March 26, 2016
    Sponsor
    Farabi Eye Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02716883
    Brief Title
    Early Amniotic Membrane Transplantation in Bacterial Keratitis
    Official Title
    Early Amniotic Membrane Transplantation in Bacterial Keratitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    April 2016 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Farabi Eye Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratitis of Both Eyes
    Keywords
    keratitis, AMT, bacterial keratitis, medication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    14 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Non AMT
    Arm Type
    No Intervention
    Arm 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
    Arm Title
    AMT
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    AMT
    Intervention Description
    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 Measure Information:
    Title
    Time to scar formation
    Description
    The time keratitis needs for scar to be formed
    Time Frame
    It needs at most 3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Early Amniotic Membrane Transplantation in Bacterial Keratitis

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