Back to resultsMechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
Primary Purpose
Refractive Error, Myopia
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Mechanical debridement
Alcohol-assisted debridement
Sponsored by
About this trial
This is an interventional prevention trial for Refractive Error focused on measuring photorefractive keratectomy, PRK, alcohol-assisted debridement, mechanical debridement, confocal scan, confocal microscopy
Eligibility 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
Sites / Locations
- Ophthalmic Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mechanical debridment
Alcohol-asstisted debridement
Arm Description
In this arm, corneal epithelium was removed during PRK using conventional mechanical method.
In this arm, corneal epithelium was removed using ethanol 20% during PRK.
Outcomes
Primary Outcome Measures
Corneal cellular elements.
Confocal microscopic findings of corneal cellular elements.
Secondary Outcome Measures
Full Information
NCT ID
NCT00918697
First Posted
June 10, 2009
Last Updated
October 12, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00918697
Brief Title
Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
Official Title
Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Myopia
Keywords
photorefractive keratectomy, PRK, alcohol-assisted debridement, mechanical debridement, confocal scan, confocal microscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mechanical debridment
Arm Type
Active Comparator
Arm Description
In this arm, corneal epithelium was removed during PRK using conventional mechanical method.
Arm Title
Alcohol-asstisted debridement
Arm Type
Experimental
Arm Description
In this arm, corneal epithelium was removed using ethanol 20% during PRK.
Intervention Type
Procedure
Intervention Name(s)
Mechanical debridement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Alcohol-assisted debridement
Intervention Description
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 Outcome Measure Information:
Title
Corneal cellular elements.
Description
Confocal microscopic findings of corneal cellular elements.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
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