Actively Recruiting
Clinical Evaluation of WaveLight Plus LASIK
Led by Laser Defined Vision · Updated on 2025-10-02
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Laser Defined Vision
Lead Sponsor
S
Sengi
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL and Low Luminance Questionnaire (LLQ-32) Questionnaire.
CONDITIONS
Official Title
Clinical Evaluation of WaveLight Plus LASIK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Willing and able to attend all scheduled study visits
- At least 18 years old
- Myopia up to -8.00 D, astigmatism up to -3.00 D, spherical equivalent more than -1.00D and up to -9.00D
- Best corrected photopic distance visual acuity of 20/20-2 or better (≤ 0.04 logMAR)
- Mesopic pupil size 4.5 mm or larger
- Less than 0.75 D difference between Sightmap refraction and subjective manifest refraction
- Stable refraction within ± 0.50 D for at least 12 months prior to surgery
- Soft contact lens wearers discontinued use for at least 3 days prior to first refraction
- RGP or toric soft contact lens wearers discontinued use for at least 2 weeks prior to first refraction
You will not qualify if you...
- Pregnant or nursing
- Acute or chronic disease increasing operative risk or confounding study outcomes
- History of flap complications
- Taking systemic medications that increase risk or confound outcomes
- Ocular conditions other than high myopia that increase complication risk such as ectasia
- History or evidence of active or inactive corneal disease
- Retinal vascular disease
- Keratoconus or keratoconus suspect
- Glaucoma or glaucoma suspect by exam or family history
- Previous intraocular or corneal surgery
- Predicted residual stromal bed thickness less than 250 µm
- Intended monovision treatment
- Participation in other current clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Laser Defined Vision
Greensboro, North Carolina, United States, 27401
Actively Recruiting
Research Team
C
Carrie Williams
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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