Actively Recruiting
Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting
Led by Laser Defined Vision · Updated on 2025-10-02
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Laser Defined Vision
Lead Sponsor
S
Sengi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating patient satisfaction, quality of vision, and quality of life after bilateral LASIK surgery using the Wavelight Plus Excimer Laser. This observational study focuses on adults with myopia and astigmatism, assessing visual outcomes under both normal and low lighting conditions. The purpose is to understand how well patients see and feel about their vision following surgery. Participants will undergo Wavelight Plus LASIK, an advanced laser eye surgery that uses personalized treatment plans based on detailed eye measurements. This study follows a single group of patients treated with this laser technology. Assessments will take place up to three months after surgery to evaluate visual acuity and refractive results. During the study, participants will have clinical eye exams to measure vision sharpness in bright and dim lighting. They will complete questionnaires about their vision quality and daily life impacts. Researchers will track changes in vision clarity and refractive stability over three months, monitoring safety and patient-reported outcomes throughout the follow-up period.
CONDITIONS
Brief Title
Clinical Evaluation of WaveLight Plus LASIK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign an informed consent form
- Willing and able to attend all scheduled study visits
- At least 18 years of age
- Myopia up to -8.00 diopters and astigmatism up to -3.00 diopters with spherical equivalent between more than -1.00 and up to -9.00 diopters
- Best corrected photopic distance visual acuity of 20/20 minus 2 or better (≤ 0.04 logMAR)
- Mesopic pupil size of 4.5 mm or larger
- Less than 0.75 diopters difference between Sightmap and subjective manifest refraction
- Stable refraction within ± 0.50 diopters for at least 12 months before surgery
- Contact lens wearers must discontinue soft lenses for at least 3 days, rigid gas permeable or toric soft lenses for at least 2 weeks before first refraction
You will not qualify if you...
- Pregnant or nursing
- Acute or chronic illness increasing operative risk or affecting study outcomes
- History of flap complications
- Use of systemic medications that may affect study outcomes or increase risk
- Ocular conditions other than high myopia that increase risk of complications, including ectasia
- History or signs of corneal diseases such as herpes keratitis, recurrent erosion, or dystrophy
- Retinal vascular disease
- Keratoconus or suspect keratoconus
- Glaucoma or suspect glaucoma
- Previous intraocular or corneal surgery
- Predicted residual stromal bed thickness less than 250 microns
- Planned monovision treatment
- Participation in other current clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate post-operative period
Participants undergo Wavelight Plus LASIK, an advanced laser eye surgery using personalized treatment plans based on comprehensive diagnostics.
1 surgery day visit and several immediate post-operative visits
Duration - 3 months postoperatively
Participants are monitored for visual outcomes and recovery over a 3-month period after surgery.
Visits at multiple timepoints during the 3 months after surgery
Trial Site Locations
Total: 1 location
1
Laser Defined Vision
Greensboro, North Carolina, United States, 27401
Actively Recruiting
Research Team
C
Carrie Williams
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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