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

September 14, 2016 updated by: Centre Hospitalier Régional Metz-Thionville

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Were included patients with myopia up to -4D (dioptries) and cylinders up to -3D.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: Month 2
LogMar
Month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-11Obs-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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