Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00918697

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error Myopia	Procedure: Mechanical debridement Procedure: Alcohol-assisted debridement	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

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

Study Start Date :

Jul 1, 2009

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Corneal cellular elements. []
Confocal microscopic findings of corneal cellular elements.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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