Comparison of Corneal Stromal Tissue Consumption (LATAC)

Disorders, Refractive Clinical Trial

— LATAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519673
• Other study ID #: JFO_2015_26
• Status: Completed
• Phase: N/A
• First received: August 4, 2015
• Last updated: March 17, 2017
• Start date: August 8, 2015
• Est. completion date: March 15, 2017

Study information

• Verified date: March 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 15, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Disorders, Refractive
• Refractive Errors

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One month