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

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ClinicalTrials.gov Identifier: NCT00344838
Recruitment Status : Unknown
Verified June 2006 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : June 27, 2006
Last Update Posted : June 27, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
To compare the results of two commercially available customized laser ablation devices.

Condition or disease Intervention/treatment
Customized Laser Ablation. 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Customized Laser Ablation: Comparing Results of LADAR Vision and VISX Platforms
Study Start Date : September 2003
Estimated Study Completion Date : June 2006
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Basic distinctions in wave capture and processing technology. Moreover, there are fundamental differences in as far as centration, registration, and ablation technology is concerned

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344838


Contacts
Contact: Janie Burroughs, B.S. 214-648-4842 Janie.Burroughs@UTSouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390-8866
Contact: Janie Burroughs, B.S.    214-648-4842    Janie.Burroughs@UTSouthwestern.edu   
Principal Investigator: James P. McCulley, M.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: James P. McCulley, M.D. University of Texas, Southwestern Medical Center at Dallas
More Information

ClinicalTrials.gov Identifier: NCT00344838     History of Changes
Other Study ID Numbers: 0903-556
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: June 27, 2006
Last Verified: June 2006

Keywords provided by University of Texas Southwestern Medical Center:
LADARWave™
WaveScan Wavefront™ Systems