Evaluation of Mesopic Visual Acuity and Patient Satisfaction Following Ray-Tracing-Guided LASIK
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorVance Thompson Vision
About this trial
To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects ages 18 to 45 years old.
Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery or stability as determined by the investigator.
Myopia with or without astigmatism and MRSE within the range of indications for wavelight plus (myopia up to -8.00D, astigmatism up to -3.00D, S.E. more than -1.00 and up to -9.00D)
Best corrected distance visual acuity (BCDVA) of 20/20 or better (≥83 letters) in each eye.
Disqualifiers
Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or have another condition with associated fluctuation of hormones that could lead to refractive changes.
Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator.
Previous corneal ocular surgery
History of evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma or glaucoma suspect.
Trial design
Design model
Single group
Treatments tested in this trial
Wavelight Plus
Devicecomprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: WaveLight PlusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Establish non-inferiority of the post-operative uncorrected mesopic distance visual acuity MVA (UC-MVA, monocular) at 6 months to the pre-operative Best Spectacle-Corrected MVA (BSC-MVA, monocular), assessed in logMAR units
Time frame
Baseline compared to 6 month post operative visit2
Patient reported outcome of overall satisfaction with vision, measured using the Patient Reported Outcomes with LASIK - Satisfaction Survey (#1 of PROWL-SS, 0-100)
Time frame
Baseline compared to 6 month post operative visitSecondary outcomes
1
Satisfaction with night vision (modified based on #1 of PROWL-SS, 0 - 100) at baseline and 6-month post-op
Time frame
Baseline compared to 6 month post operative visit2
Difficulty driving at night (from PROWL, Top-2-box) at baseline and 6-month post-op
Time frame
Baseline compared to 6 month post operative visit3
Frequency of starbursts or halo that bother you (PROWL, Top-2-box) at baseline and 6-month post-op
Time frame
Baseline compared to 6 month post operative visit4
Mesopic contrast sensitivity measured with and without glare (binocular) at baseline and 6-month post-op+
Time frame
Baseline compared to 6 month post operative visitOther outcomes
1
Other night vision questions and VND-Q (item 1-4, Top-2-box of each) at baseline and 6-month post-op
Time frame
Baseline compared to 6 month post operative visit2
Other domain scores of PROWL-SS (glare, halo, starbursts)
Time frame
Baseline compared to 6 month post operative visit3
BOSA tear film analysis at baseline and 6-month post-op
Time frame
Baseline compared to 6 month post operative visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vance Thompson Vision
Lead sponsor
Alcon, a Novartis Company
Collaborator
Source ClinicalTrials.gov