Optical Coherence Pachymetry to Evaluate Central Corneal Ablation Depth in Myopic Femtosecond Laser in Situ Keratomileusis (PACO)

March 17, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Optical Coherence Pachymetry (OCP) to Evaluate Central Corneal Ablation Depth in Myopic Femtosecond Laser in Situ Keratomileusis (LASIK)

Prospective study aiming to measure central ablation depth during excimer laser surgery in myopic patients operated with femtosecond laser assisted LASIK with intraoperative OCP, before and after laser ablation. This measurement will be compared with pre and 1 month postoperative topography differential pachymetric measurements.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • SALOMON

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

patients undergoing refractive surgery with LASIK

Description

Inclusion Criteria:

  • Patients over 18 years old
  • undergoing refractive surgery with LASIK
  • with myopic or compound myopic astigmatism ametropia
  • without irregular cornea and topographical sign of keratoconus
  • preoperative corneal thickness compatible with LASIK

Exclusion Criteria:

  • hyperopia
  • opposition to participate in the study
  • no health insurance coverage
  • patient under legal protection
  • pregnant or breastfeeding patient

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
depth of central corneal ablation
Time Frame: 1 month after surgery
measured in microns with OCP
1 month after surgery

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Jean-Luc FEBBRARO, MD, Fondation OPH A de Rothschild

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 (Actual)

May 26, 2014

Primary Completion (Actual)

July 26, 2016

Study Completion (Actual)

March 15, 2017

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JFO_2013-15

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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