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

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Completed
CT.gov ID
NCT02893592
Collaborator
(none)
118
Enrollment
5
Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    118 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Mar 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. visual acuity [Month 2]

      LogMar

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Régional Metz-Thionville

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Régional Metz-Thionville
    ClinicalTrials.gov Identifier:
    NCT02893592
    Other Study ID Numbers:
    • 2015-11Obs-CHRMT
    First Posted:
    Sep 8, 2016
    Last Update Posted:
    Sep 15, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Sep 15, 2016