Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy

Completed

• Conditions: Myopia

• Registration Number: NCT02893592
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

The photorefractive keratectomy was the first correction mode refractive laser. It's a photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Trans-PRK has a lot of interests: facility and speed of procedure as well as suppression of human variable. Very good results are obtained by m-PRK. The aim of this study is to show equivalence or non inferiority of trans-PRK over conventional m-PRK in terms of safety and refractive efficiency

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2015-11
• Study Completion: 2016-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• patients with stable refractive error (more than 2 years)
• Myopia up to -4.00 diopters and astigmatism up to -3.00 diopters

Exclusion Criteria

• Phototherapeutic keratectomy (PTK)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual acuity	Month 2	LogMar