A Comparison of Two Devices for Measuring the Central Thickness of the Cornea Before and After Surgery (CECOT)

Disorders, Refractive Clinical Trial

— CECOT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522416
• Other study ID #: JFO_2015_30
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: March 17, 2017
• Start date: November 30, 2015
• 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
• Study type: Observational

Clinical Trial Summary

Corneal topography allows the measure of the radii of curvature and of the thickness of the cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal irregularities such as a keratoconus, or too thin corneas which are a contra-indication for laser refractive surgery.

Several types of corneal topographers are commercially available. Some as the Orbscan(r), operate by analyzing the image of the patterns of a Placido disk associated with a light slit, allowing the collection of thousands of points of the anterior and posterior surface of the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary cameras which capture images of the whole anterior segment of the eye. The aim of this study is to compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the central corneal pachymetry measurements measured pre- and postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 15, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients for whom a LASIK refractive surgery is planned

Exclusion Criteria:

• hyperopic patient

• another refractive surgery technique

• pregnant or lactating woman

• patient's opposition to participation in the study, according to the law on research into routine care

• patient under a measure of legal protection

• absence of affiliation to social security

Related Conditions & MeSH terms

• Disorders, Refractive
• Refractive Errors

Intervention

Device:
• Central corneal thickness measurement

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	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	Concordance of the Orbscan and Pentacam topographs, evaluated by the intra-class correlation coefficient, for the measure of the difference of the central thickness of the cornea before and after surgery.		one month