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

Study ID
0903-556

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services

Contact


Principal Investigator

Official Title

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

Brief Overview


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

Summary


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.

Participant Eligibility


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.