Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

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.

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Key information

Conditions

Refractive Error Eye Diseases Myopia Refractive Errors

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

spherical equivalent ≤ -4.0 D
cylinder ≤ 1.50 D

Exclusion criteria

history of ocular trauma or surgery
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

Treatment and study plan

Mechanical debridement

Procedure

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

Procedure

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.

Primary outcomes

Corneal cellular elements.

Confocal microscopic findings of corneal cellular elements.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Study completion: 2010
First posted: Jun 11, 2009
Registry last updated: Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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