Mechanical vs. Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures

Keratomileusis, Laser In Situ Clinical Trial

Official title: Mechanical vs. Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures

Status Completed

Clinical Trial Summary

A recent survey of trends among the members of the American Society of Cataract and Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading surgical procedure for photorefractive corrections ranging from −0 to 3 diopters (D).1 The same survey, however, showed a clear trend of participating refractive surgeons toward surface ablation. Photorefractive keratectomy (PRK) was the first refractive surgery procedure approved and performed using the excimer laser. Several techniques of epithelial debridement have been tried with PRK-type surgery including mechanical debridement, laser transepithelial ablation, a rotating brush, and alcohol debridement.

The Amadeus II microkeratome (Advanced Medical Optics Inc, Irvine, CA, USA) used for the creation of a LASIK flap has an upgradeable platform that will allow the user to perform mechanical separation of the corneal epithelium before photorefractive treatments. With the use of this device, the corneal epithelium can be separated from the underlying stroma without previous preparation of the corneal surface with alcohol. The separated epithelial sheet can either be removed or replaced on the operated cornea after photoablation. This surgical procedure, which has been called Epi-LASIK, represents an advanced alternative surface ablation photorefractive procedure for the correction of ametropia. The purpose of this study is to evaluate the clinical visual outcomes, healing rates, and patient satisfaction when performing surface ablation procedures using mechanical vs. alcohol separation of the epithelium.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Keratomileusis, Laser In Situ

• NCT number: NCT00366808
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: Phase 4
• Start date: February 2006
• Completion date: August 2007