Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344838
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2006-06-23
Brief Title:
Customized Laser Ablation Comparing Results of LADAR Vision and VISX Platforms
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Customized Laser Ablation Comparing Results of LADAR Vision and VISX Platforms
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the results of two commercially available customized 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None