WaveLight Plus LASIK and how it affects vision and patient satisfaction

Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK

This study tries WaveLight Plus LASIK in adults 18–39 with myopia and astigmatism to see if vision, satisfaction, and quality of life improve in the three months after surgery.

Quick facts

• Study type: Observational
• Enrollment: 52 (estimated)
• Ages: 18 Years to 39 Years
• Sex: All
• Sponsor: Mann Eye Institute (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07084844 on ClinicalTrials.gov

What this trial studies

This is a single-site, single-arm, prospective observational study of bilateral WaveLight Plus LASIK with follow-up to three months post-operatively. Participants will undergo standard clinical exams including refractive outcomes and visual acuity measurements. Patient-reported outcomes will be collected using adapted PROWL items and the Quality-of-Life Impact of Refractive Correction (QIRC) questionnaire. The study focuses on subject satisfaction, quality of vision, and quality of life rather than comparing against a control group.

Who should consider this trial

Good fit: Ideal candidates are adults 18–39 who meet standard LASIK criteria with stable refraction, spherical equivalent between −1.00D and −9.00D (myopia ≤ −8.00 sphere) with up to −3.00D astigmatism, pre-surgery BCDVA of 20/20 or better, mesopic pupil ≥4.5 mm, and sufficient residual stromal bed thickness.

Not a fit: Patients with prior ocular surgery, topographic signs of keratoconus or ectasia, autoimmune disease, unstable refraction, insufficient residual stromal bed, or refractive errors outside the eligible range are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, the study could demonstrate that WaveLight Plus LASIK yields good refractive results and higher patient satisfaction and quality of life after surgery.

How similar studies have performed: Previous LASIK outcome studies and PROWL/QIRC-based assessments have generally reported high patient satisfaction and good refractive outcomes with modern excimer platforms, so this study builds on established results.

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

Where this trial is running

Houston, Texas

• Mann Eye Institute — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Phillip Brunson — Mann Eye Institute
• Study coordinator: Study Coordinator

Conditions: Myopia, Astigmatism