Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00918697

Enrollment

Registered

2009-06-11

Start date

2009-07-31

Completion date

2010-03-31

Last updated

2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Error, Myopia

Keywords

photorefractive keratectomy, PRK, alcohol-assisted debridement, mechanical debridement, confocal scan, confocal microscopy

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.

Interventions

PROCEDUREMechanical 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.

PROCEDUREAlcohol-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Corneal cellular elements.	—	Confocal microscopic findings of corneal cellular elements.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026