CClinicalTrials.gg
CompletedNCT02519673LATACUpdated Mar 20, 2017

Comparison of Corneal Stromal Tissue Consumption (LATAC)

An observational study in Disorders, Refractive, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-20.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Disorders, Refractive

Browse trials for

03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 50 is below the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • DeviceMeasurement 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.

06

What researchers measure

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

    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.

    Time frame: One month

07

Study locations

1 site
  • Fondation ophtalmique Adolphe de Rothschild
    Paris, 75019, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02519673
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Aug 11, 2015
Start date
Aug 8, 2015
Primary completion
Jan 18, 2017
Completion
Mar 15, 2017
Last update
Mar 20, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion