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Early Amniotic Membrane Transplantation in Bacterial Keratitis

Early Amniotic Membrane Transplantation in Bacterial Keratitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02716883
Enrollment
14
Registered
2016-03-23
Start date
2014-01-31
Completion date
2016-04-30
Last updated
2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratitis of Both Eyes

Keywords

keratitis, AMT, bacterial keratitis, medication

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)

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.

Sponsors

Farabi Eye Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to scar formationIt needs at most 3 monthsThe time keratitis needs for scar to be formed

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026