Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918697
• Other study ID #: 8713
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2009
• Last updated: October 12, 2010
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal cellular elements.	Confocal microscopic findings of corneal cellular elements.		Yes