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NCT02893592 Clinical Trial

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

Myopia Clinical Trial

— MYOPAS  

Official title:
Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy (Trans-PRK) for Low and Medium Myopia and Astigmatism: Retrospective Study About 118 Eyes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02893592
Other study ID # 2015-11Obs-CHRMT
Secondary ID
Status Completed
Phase N/A
First received August 30, 2016
Last updated September 14, 2016
Start date October 2015
Est. completion date March 2016

Study information
Verified date August 2016
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 118
Est. completion date March 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome
Type Measure Description Time frame Safety issue
Primary visual acuity LogMar Month 2 No
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