Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK

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 the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: f
View:

• Between the ages of 18 and 39

• Meet the standard care requirements for LASIK

• Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters

• Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism

• SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D

• Minimum residual stromal bed thickness of 250 µm

• If currently wearing contact lenses:

‣ Soft CTL wearers discontinue for minimum 3 days

⁃ RGP CTL wearers discontinue for 1 month per decade of wear

• Stable refraction (2 consecutive manifest refractions within 0.25 SE)

• Stable K readings (2 consecutive K readings in 2 consecutive visits)

• Willing and able to complete all post-operative visits

• Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm

Locations
United States
Texas
Mann Eye Institute
RECRUITING
Houston
Contact Information
Primary
Study Coordinator
Melissa.Wright@manneye.com
713-580-2500
Time Frame
Start Date: 2025-09-05
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 52
Related Therapeutic Areas
Sponsors
Leads: Mann Eye Institute
Collaborators: Sengi

This content was sourced from clinicaltrials.gov