Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Subject must be able to understand and sign an IRB approved Informed consent form

• Willing and able to attend all scheduled study visits as required per protocol

• Minimum of 18 years of age

• Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction

• Best corrected photopic distance visual acuity of 20/20-2 or better (≤ 0.04 logMAR)

• Mesopic pupil size ≥ 4.5mm

• Less than 0.75 D manifest refraction spherical equivalent difference between Sightmap refraction and subjective manifest refraction

• Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery, verified by consecutive subjective refractions or medical records or prescription history

• If currently wearing contact lenses:

‣ Soft CTL wearers discontinue for minimum 3 days prior to first refraction

⁃ RGP or toric soft CTL wearers discontinue for ≥2 weeks prior to first refraction

Locations
United States
North Carolina
Laser Defined Vision
RECRUITING
Greensboro
Contact Information
Primary
Carrie Williams
ldv2020@gmail.com
336-288-8823
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 50
Treatments
Wavelight Plus LASIK
Related Therapeutic Areas
Sponsors
Collaborators: Sengi
Leads: Laser Defined Vision

This content was sourced from clinicaltrials.gov