Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

NCT00918697 | Completed Phase 2

• 1 other identifier: 8713
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Error; Myopia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Corneal cellular elements.

  Confocal microscopic findings of corneal cellular elements.

Study Arms (2)

Mechanical debridment

ACTIVE COMPARATOR

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

Procedure: Mechanical debridement

Alcohol-asstisted debridement

EXPERIMENTAL

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

Procedure: Alcohol-assisted debridement

Interventions

Mechanical debridement PROCEDURE

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.

Mechanical debridment

Alcohol-assisted debridement PROCEDURE

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.

Alcohol-asstisted debridement

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• spherical equivalent ≤ -4.0 D
• cylinder ≤ 1.50 D

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: July 1, 2009
• Study Completion: March 1, 2010
• Last Updated: October 13, 2010

Record last verified: 2010-04

Locations

IR (1)