Patient Reported Outcomes With WaveLight Plus LASIK

NCT07084844 | Recruiting FDA Device

• 1 other identifier: PB-25-02
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only).

  3 months postoperative

Secondary Outcomes (3)

• PROWL-SS Questionnaire

  3 months postoperative

• OSDI Score

  3 months postoperative

• Uncorrected distance visual acuity

  3 months postoperative

Other Outcomes (3)

• Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire

  3 months postoperative

• Manifest Refraction Spherical Equivalent

  3 months postoperative

• Cylinder

  3 months postoperative

Interventions

WaveLigh Plus LASIK DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible test subjects will be 18 to 39 years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mann Eye Institute: lead
• Sengi: collaborator

Study Sites (1)

Mann Eye Institute

Houston, Texas, 77004, United States

RECRUITING

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Phillip Brunson

  Mann Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

713-580-2500; Melissa.Wright@manneye.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 25, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)