NCT02893644

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

August 30, 2016

Last Update Submit

March 17, 2017

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • depth of central corneal ablation

    measured in microns with OCP

    1 month after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing refractive surgery with LASIK

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SALOMON

Paris, 75019, France

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Jean-Luc FEBBRARO, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 8, 2016

Study Start

May 26, 2014

Primary Completion

July 26, 2016

Study Completion

March 15, 2017

Last Updated

March 20, 2017

Record last verified: 2017-03

Locations

FR(1)