Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK) - Full Text View

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00918697

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 II

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:

MedlinePlus related topics: Refractive Errors

Drug Information available for: Ethanol

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.

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 February 09, 2012