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Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00918697
First received: June 10, 2009
Last updated: October 12, 2010
Last verified: April 2010
  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:


Further study details as provided by Shahid 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Shahid 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 Shahid Beheshti Medical University:
photorefractive keratectomy
PRK
alcohol-assisted debridement
mechanical debridement
confocal scan
confocal microscopy

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

ClinicalTrials.gov processed this record on November 25, 2014