Comparison of Corneal Stromal Tissue Consumption (LATAC)

NCT ID: NCT02519673

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-08
• Study Completion Date: 2017-03-15

Brief Summary

In refractive surgery, stromal ablation depth is fundamental because it determines the thickness of the residual posterior wall. The posterior wall is an essential element that guarantees the refractive stability and the long term prevention of corneal ectasia after corneal refractive surgery. A minimum thickness of more or less 300 microns is universally accepted. Its calculation is based on well-known formulas, such as Munnerlynn ones.

With the excimer laser platform last generation WaveLight® Allegretto® EX-500 of Alcon, a new treatment option called "wavefront optimized" is offered for myopia, astigmatism and hyperopia. The ablation profile has been developed to save stromal tissue consumption and to favor the quality of vision, by optimizing connections between the optical zone and the transition zone of the photoablation. Alongside the theoretical formulas, evaluation of the depth of ablation may be defined by differential ultrasonic pachymetry or by topographical analysis pre and postoperatively. The latter is currently the method of reference to assess the corneal thickness.

Conditions

Disorders, Refractive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Measurement of stromal tissue ablation

Stromal tissue consumption will be estimated preoperatively by WaveLight Allegretto EX-500 laser and central corneal thickness will be measured by Pentacam. One month after refractive surgery, during follow-up,central corneal thickness will be again measured by Pentacam.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients having a refractive disorder and for whom a refractive surgery is programmed.

Exclusion Criteria

• Patient opposed to participation in the study
• Another refractive surgery technique
• Hyperopic patient
• Pregnant or lactating woman
• Patient under a measure of legal protection
• Absence of affiliation to social security or universal health coverage (CMU)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondation ophtalmique Adolphe de Rothschild

Paris, Paris, France

Countries

France

Other Identifiers

JFO_2015_26

Identifier Type: -

Identifier Source: org_study_id