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Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00918697
First received: June 10, 2009
Last updated: October 12, 2010
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • Corneal cellular elements. [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918697

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on May 23, 2013