Patient Reported Outcomes With WaveLight Plus LASIK
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WaveLigh Plus LASIK.
- Who it may be relevant to
- Registry conditions: Myopia, Astigmatism. Basic parameters: 18 years — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK
Overview
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.
Interventions
- Device WaveLigh Plus LASIK
Wavelight plus LASIK is an advanced laser eye surgery technology designed to enhance visual outcomes through personalized treatment plans. This system integrates comprehensive diagnostics, including biometry, tomography, and wavefront measurements, to create a tailored ablation profile for each patient.
Primary outcome measures
- Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only). [Time frame: 3 months postoperative]
Secondary outcome measures (3)
- PROWL-SS Questionnaire [Time frame: 3 months postoperative]
- OSDI Score [Time frame: 3 months postoperative]
- Uncorrected distance visual acuity [Time frame: 3 months postoperative]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Subjects with any prior ocular surgery
- Subjects with topographic evidence of keratoconus, or ectasia
- Subjects with autoimmune diseases
- Subjects who are pregnant or nursing
- Systemic disease likely to affect wound healing, such as diabetes and severe atopy
- Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mann Eye Institute — Houston
Identifiers
NCT: NCT07084844 · PB-25-02