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
|Condition or disease||Intervention/treatment||Phase|
|Keratitis of Both Eyes||Procedure: AMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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.
- Time to scar formation [ Time Frame: It needs at most 3 months ]The time keratitis needs for scar to be formed