Eye Burns Clinical Trial
This is a randomized clinical trial study to identify the role of AMT (amniotic membrane transplantation) in treating epithelial defect, symblepharon prevention preventing corneal vascularization and opacity decreasing pain and improving visual acuity, and patients with acute chemical burns.
The study is on patients with grade II-IV acute ocular chemical burns (Roper - Hall
classification) in the first 2 weeks of injury.
After topical anesthesia, all patients initially will receive first aid therapy; which
included irrigation with normal saline to normalize ocular surface PH and removal of early
particulate maeuil and debris. After complete examination and obtaining informed consent,
the patients will be randomized using a treatment assignment list to either AMT with
conventional medical therapy (group A) or medical treatment only (group B). In the patients
with bilateral injuries the eyes will be randomized separately. AMT will be performed within
24h of presentation. amniotic membrane will remain in place for 7-14 days. The patients will
be examined at days 1, 3, 7, 10, 14, 21, 28 and then biweekly until 3 months and monthly
until (1 year in every visit, visual acuity (by sneillen charts), reduction of pain
(subjectively) size of corneal epithelial defect (by fluorseein satiny extent of corneal
vascularization and opacity, and symblepharon formation will be assessed. Digital
photographs at each visit will be obtained.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
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Not yet recruiting |
NCT01886560 -
Low Dose Doxycycline in the Treatment of Corneal Burn
|
Phase 2/Phase 3 |