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NCT Number: NCT07084844

Patient Reported Outcomes With WaveLight Plus LASIK

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mann Eye Institute

Houston, Texas, 77004, United States

Location status: Recruiting

Location contact

Phillip Brunson

PRINCIPAL_INVESTIGATOR

Study Coordinator

CONTACT

[email protected]

713-580-2500 ext. 2389

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

    Time frame: 3 months postoperative

Secondary outcomes

  1. PROWL-SS Questionnaire

    Time frame: 3 months postoperative

    PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items).

  2. OSDI Score

    Time frame: 3 months postoperative

    The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.

  3. Uncorrected distance visual acuity

    Time frame: 3 months postoperative

    % of eyes in each level of uncorrected visual acuity (e.g. 20/20, 20/16, 20/12.5, 20/10 with logMAR chart).

Other outcomes

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

    Time frame: 3 months postoperative

    QIRC can be used to measure the quality of life of people who require an optical correction (spectacles, contact lenses or refractive surgery). Subjects select one of 6 responses for each question (20 questions total). Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome.

  2. Manifest Refraction Spherical Equivalent

    Time frame: 3 months postoperative

    Percentage of eyes with post-op spherical equivalent within +/- 0.25D, 0.50D, and 0.75D respectively.

  3. Cylinder

    Time frame: 3 months postoperative

    Percentage of eyes with post-op cylinder within +/- 0.25D, 0.50D, and 0.75D respectively.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

713-580-2500 ext. 2389

Sponsors and collaborators

Lead sponsor

Mann Eye Institute

Other

Collaborators

  • Sengi

Registry information

Official study title

Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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