Clinical Trials Directory

Trials / Completed

CompletedNCT02519673

Comparison of Corneal Stromal Tissue Consumption (LATAC)

Comparison of Corneal Stromal Tissue Consumption Values Estimated When Programming the Intervention Versus the Values Measured by Pre and Postoperative Topography

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEMeasurement of stromal tissue ablationStromal 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.

Timeline

Start date
2015-08-08
Primary completion
2017-01-18
Completion
2017-03-15
First posted
2015-08-11
Last updated
2017-03-20

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02519673. Inclusion in this directory is not an endorsement.