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Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918697
First Posted: June 11, 2009
Last Update Posted: October 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
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: Quadruple (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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918697


Locations
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
ClinicalTrials.gov Identifier: NCT00918697     History of Changes
Other Study ID Numbers: 8713
First Submitted: June 10, 2009
First Posted: June 11, 2009
Last Update Posted: October 13, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs