Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

Study Overview
=================
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.

Official Title
-----------------
Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial

Conditions
-----------------
Refractive Error, Myopia

Intervention / Treatment
-----------------
* Procedure: Mechanical debridement
* Procedure: Alcohol-assisted debridement


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanical debridment<br>In this arm, corneal epithelium was removed during PRK using conventional mechanical method. | Procedure: Mechanical debridement<br>* 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.<br>|
| Experimental: Alcohol-asstisted debridement<br>In this arm, corneal epithelium was removed using ethanol 20% during PRK. | Procedure: Alcohol-assisted debridement<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal cellular elements. | Confocal microscopic findings of corneal cellular elements. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
photorefractive keratectomy, PRK, alcohol-assisted debridement, mechanical debridement, confocal scan, confocal microscopy