Comparison of Corneal Stromal Tissue Consumption (LATAC)

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Completed
• CT.gov ID: NCT02519673
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 19.2
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disorders, Refractive	Device: Measurement of stromal tissue ablation

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Corneal Stromal Tissue Consumption Values Estimated When Programming the Intervention Versus the Values Measured by Pre and Postoperative Topography
• Actual Study Start Date: Aug 8, 2015
• Actual Primary Completion Date: Jan 18, 2017
• Actual Study Completion Date: Mar 15, 2017

Outcome Measures

Primary Outcome Measures

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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation ophtalmique Adolphe de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT02519673
• Other Study ID Numbers: JFO_2015_26
• First Posted: Aug 11, 2015
• Last Update Posted: Mar 20, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Refractive Errors

Study Results

No Results Posted as of Mar 20, 2017