Customized Laser Ablation: Comparing Results of LADAR Vision and VISX Platforms

To compare the results of two commercially available customized laser ablation devices.

Study Overview

• Status: Completed
• Conditions: Customized Laser Ablation
• Intervention / Treatment: Device: Comparison of LADAR CustomLasik and VISX Wavefront System custom laser ablation devices

Detailed Description

In the past few years, several custom laser ablation platforms have emerged in the marketplace but only two are currently approved by the FDA. They are the LADAR CustomLasik (Alcon: Ft. Worth, TX) and the VISX Wavefront System (VISX: Santa Clara, CA). Although both use the Hartmann-Shack wave sensing principle, there are some basic distinctions in wave capture and processing technology. Moreover, there are fundamental differences in as far as centration, registration, and ablation technology is concerned. Evaluating and comparing the results of these two systems in assorted categories of patients would help us select the appropriate laser platform for the patient.

Once a patient has been scheduled to undergo customized laser ablation, they will have a routine preoperative examination. The following tests will be gathered and evaluated by the doctor in order to determine eligibility for the treatment. If the patient qualifies for custom laser ablation, this information will also be used for the study as long as they give written consent.

Pre-operative Visit (Screening visit): Date of Visit, Patient Initials, Date of Birth, Sex, Race, Assessment of visual needs, Ocular history, History of contact lens wear, Medical history, Allergies to food and drugs, Medication, family history, Distance and Near Vision (with and without correction), Auto-refraction, Refraction, eye dominance, Keratometry, Visual Acuity, Pupil size (bright and dim lighting), Afferent Pupillary Defect (ADP), Ocular motility, Ophthalmoscopy, Cycloplegic refraction, Pachymetry, Intaocular Pressure test, Custom Vue (VISX), LADARWave (LADAR), and Schirmers testing with anesthetic. Typically, these procedures are employed as part of "standard of care" for patients who are seeking custom LASIK treatment. Furthermore, there will be two additional procedures that will be performed as "reseach" measures . These are visual acuity with an Early Treatment Diabetic Retinopathy Study (ETDRS) vision chart and contrast sensitivity.

Post-Operative visits (Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12): ETDRS Visual Acuity, contrast sensitivity along with a questionnaire pertaining to the study patients visual problems and experience will be completed by the patient at week 1 and after each visit thereafter. These procedures are intended as part of research.

Additional data gathered as part of "standard of care" will include: date of visit, patient initials, visual acuity, refraction, Intraocular Pressure (discretion of physician), Custom Vue (VISX) and LADARWave. Both Custom Vue and LADAR measurements are taken at 3-month visit only!

The research project proposes to compare the results of two FDA approved laser ablation treatment methods. While both treatment modalities are considered standard of care for those who decide to perform customized laser treatment, the "comparison" is intended as part of this research project.

• Study Type: Observational
• Enrollment (Actual): 458

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-8866
      • University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Refractive Surgery Eligible Candidates

Description

Inclusion Criteria: Individuals of both genders, aged 18 and older, who have been scheduled to undergo customized laser ablation will be considered for this prospective study.

Exclusion Criteria: There are no exclusion criteria available for this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aberration Assessment	Visual Acuity aberration pre-and post-treatment	12 Months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: James P. McCulley, M.D., University of Texas, Southwestern Medical Center at Dallas

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: June 23, 2006
• First Submitted That Met QC Criteria: June 23, 2006
• First Posted (Estimate): June 27, 2006

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 28, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: LADARWave™; WaveScan Wavefront™ Systems
• Other Study ID Numbers: 0903-556