Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Myopia; Refractive Error

Treatments: Procedure: Alcohol-assisted debridement; Procedure: Mechanical debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT00918697

8713

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups

Mechanical debridment

Active Comparator group

Description:

In this arm, corneal epithelium was removed during PRK using conventional mechanical method.

Treatment:

Procedure: Mechanical debridement

Alcohol-asstisted debridement

Experimental group

Description:

In this arm, corneal epithelium was removed using ethanol 20% during PRK.

Treatment:

Procedure: Alcohol-assisted debridement