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Status unknownNCT02716883Updated Mar 29, 2016

Early Amniotic Membrane Transplantation in Bacterial Keratitis

An interventional study of AMT in Keratitis of Both Eyes, sponsored by Farabi Eye Hospital. Status unknown. Per ClinicalTrials.gov, last updated 2016-03-29.

Sponsored by Farabi Eye Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Sex
All
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Study summary

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

Read the 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)

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Conditions studied

  • Keratitis of Both Eyes

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Keywords

  • keratitis
  • AMT
  • bacterial keratitis
  • medication
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In context

Keratitis

126 studies on the registry are indexed under Keratitis; 15 are open to participants now.

This study's planned enrollment of 14 is below the median of 36 across 79 interventional studies indexed under Keratitis.

Browse Keratitis studies →

Lead sponsor

Farabi Eye Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

thinning limbal extension intraocular extension underlying disease Nocardia keratitis

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
14 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureAMT

    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.

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What researchers measure

Primary outcomes

  1. Time to scar formation

    The time keratitis needs for scar to be formed

    Time frame: It needs at most 3 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02716883
Lead sponsor
Farabi Eye Hospital
Responsible party
mohammad soleimani (Assistant Professor, Farabi Eye Hospital) — Principal investigator
First posted
Mar 23, 2016
Start date
Jan 2014
Primary completion
Apr 2016 (estimated)
Completion
Apr 2016 (estimated)
Last update
Mar 29, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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