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OpenTrials
Completed

NCT Number: NCT02519673

Comparison of Corneal Stromal Tissue Consumption (LATAC)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation ophtalmique Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Measurement of stromal tissue ablation

Device

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.

Primary outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: LATAC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2015
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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