Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-59
SponsorStanford University
About this trial
We are enrolling participants aged 22 and older to have LASIK surgery in both eyes. We will perform wavefront-guided LASIK in one eye and ray tracing-guided LASIK in the fellow eye of each participant. We are trying to see if there are any differences in the efficacy between the two types of LASIK procedures.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 22 and older
No abnormal corneal shape
No excessively thin corneas
No eye diseases such as glaucoma or cataracts
Disqualifiers
Subjects under the age of 22.
Subjects with excessively thin corneas.
Subjects with topographic evidence of keratoconus.
Subjects with ectactic eye disorders.
Trial design
Design model
Single group
Treatments tested in this trial
LASIK
Procedure/SurgeryWavefront-guided LASIK is being performed in one eye and Ray-tracing guided LASIK is being performed in the fellow eye
LASIK
Procedure/SurgeryRay-tracing guided LASIK is being performed in one eye and Wavefront-guided LASIK is being performed in the fellow eye.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Wavefront-guided laser ablationActive comparator 1 intervention
Group B: Ray tracing-guided LASIKActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Uncorrected visual acuity
Uncorrected visual acuity using ETDRS charts
Time frame
One yearSecondary outcomes
1
5 and 25% best corrected low contrast visual acuity
Measurement of the change in 5 and 25% best corrected low contrast visual acuity using ETDRS charts
Time frame
12 months2
Achieved versus attempted ablation depth measured by anterior segment OCT
Measurement of achieved ablation depth by comparing preoperative anterior segment OCT to postoperative anterior segment OCT
Time frame
One, three and twelve months3
Self reported quality of vision and quality of life measures
A validated questionnaire will be administered preoperatively and at postoperative months 3, 6 and 12
Time frame
Three, six and twelve monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov