Customized Laser Ablation: Comparing Results of LADAR Vision and VISX Platforms
Recruitment status was Recruiting
|First Received Date ICMJE||June 23, 2006|
|Last Updated Date||June 23, 2006|
|Start Date ICMJE||September 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Basic distinctions in wave capture and processing technology. Moreover, there are fundamental differences in as far as centration, registration, and ablation technology is concerned|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Customized Laser Ablation: Comparing Results of LADAR Vision and VISX Platforms|
|Official Title ICMJE||Customized Laser Ablation: Comparing Results of LADAR Vision and VISX Platforms|
To compare the results of two commercially available customized laser ablation devices.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Customized Laser Ablation.|
|Intervention ICMJE||Device: Comparison of LADAR CustomLasik and VISX Wavefront System custom laser ablation devices|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Completion Date||June 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Ages||18 Years to 88 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00344838|
|Other Study ID Numbers ICMJE||0903-556|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Texas Southwestern Medical Center|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Texas Southwestern Medical Center|
|Verification Date||June 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP