Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
NCT ID: NCT00918697
Last Updated: 2010-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2009-07-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Mechanical debridment
In this arm, corneal epithelium was removed during PRK using conventional mechanical method.
Mechanical debridement
For mechanical epithelial removal, an 8.0-mm optical zone marker was applied to the cornea, centering over the entrance pupil. A hockey spatula was used to remove the central corneal epithelium.
Alcohol-asstisted debridement
In this arm, corneal epithelium was removed using ethanol 20% during PRK.
Alcohol-assisted debridement
For alcohol-assisted debridement, 20% ethyl-alcohol solution was instilled into an 8.0-mm well and kept in contact with epithelium for 20 seconds (being careful to avoid spillage over the areas not being treated). It then absorbed using a dry cellulose sponge followed by copious irrigation with BSS. The epithelium of the central cornea was removed using a blunt spatula.
Interventions
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Mechanical debridement
For mechanical epithelial removal, an 8.0-mm optical zone marker was applied to the cornea, centering over the entrance pupil. A hockey spatula was used to remove the central corneal epithelium.
Alcohol-assisted debridement
For alcohol-assisted debridement, 20% ethyl-alcohol solution was instilled into an 8.0-mm well and kept in contact with epithelium for 20 seconds (being careful to avoid spillage over the areas not being treated). It then absorbed using a dry cellulose sponge followed by copious irrigation with BSS. The epithelium of the central cornea was removed using a blunt spatula.
Eligibility Criteria
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Inclusion Criteria
* cylinder ≤ 1.50 D
Exclusion Criteria
* any corneal and ocular pathologies
* central corneal thickness \< 500 µm
* scotopic pupil diameter \> 6.0 mm
* any abnormalities in corneal plain or elevation topographies favoring keratoconus or other ectatic disorders
* the presence of systemic disorders such as collagen vascular diseases
20 Years
40 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Shahid Beheshti University of Medical Sciences
Locations
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Ophthalmic Research Center
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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8713
Identifier Type: -
Identifier Source: org_study_id