Comparison of Corneal Stromal Tissue Consumption (LATAC)

Completed

• Conditions: Disorders, Refractive

• Registration Number: NCT02519673
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-04
• Study Start: 2015-08-08
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-11
• Primary Completion: 2017-01-18
• Status Verified: 2017-03
• Study Completion: 2017-03-15
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between stromal tissue consumption, expressed in micrometers, estimated before surgery by WaveLight Allegretto EX-500 laser and measured one month after surgery by Pentacam	One month	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. The difference between the estimated and the measured tissue consumption will be calculated.

Trial Locations

Locations (1)

Fondation ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France