Clinical Trials Directory

Trials / Completed

CompletedNCT00918697

Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Shahid Beheshti University of Medical Sciences · Academic / Other
Sex
All
Age
20 Years – 40 Years
Healthy volunteers
Not accepted

Summary

In this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical equivalent less than -4.00 D who completed all follow-up visits were evaluated.

Conditions

Interventions

TypeNameDescription
PROCEDUREMechanical debridementFor 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.
PROCEDUREAlcohol-assisted debridementFor 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.

Timeline

Start date
2009-07-01
Completion
2010-03-01
First posted
2009-06-11
Last updated
2010-10-13

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT00918697. Inclusion in this directory is not an endorsement.