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NCT02893644 Clinical Trial

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

Myopia Clinical Trial

— PACO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02893644
Other study ID # JFO_2013-15
Secondary ID
Status Completed
Phase N/A
First received August 30, 2016
Last updated March 17, 2017
Start date May 26, 2014
Est. completion date March 15, 2017

Study information
Verified date March 2017
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 15, 2017
Est. primary completion date July 26, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France SALOMON Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary depth of central corneal ablation measured in microns with OCP 1 month after surgery
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