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Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

This study has been completed.
Information provided by:
Shahid Beheshti University of Medical Sciences Identifier:
First received: June 10, 2009
Last updated: October 12, 2010
Last verified: April 2010
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.

Condition Intervention Phase
Refractive Error Myopia Procedure: Mechanical debridement Procedure: Alcohol-assisted debridement Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Corneal cellular elements.
    Confocal microscopic findings of corneal cellular elements.

Enrollment: 33
Study Start Date: July 2009
Study Completion Date: March 2010
Arms Assigned Interventions
Active Comparator: Mechanical debridment
In this arm, corneal epithelium was removed during PRK using conventional mechanical method.
Procedure: 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.
Experimental: Alcohol-asstisted debridement
In this arm, corneal epithelium was removed using ethanol 20% during PRK.
Procedure: 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.


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00918697

Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
  More Information

Responsible Party: Ophthalmic Research Center,, Shahid Beheshti University of Medical Sciences Identifier: NCT00918697     History of Changes
Other Study ID Numbers: 8713
Study First Received: June 10, 2009
Last Updated: October 12, 2010

Keywords provided by Shahid Beheshti University of Medical Sciences:
photorefractive keratectomy
alcohol-assisted debridement
mechanical debridement
confocal scan
confocal microscopy

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on June 23, 2017