Recruiting

LASIK

Sponsor:

Mann Eye Institute

Code:

NCT07084844

Conditions

Myopia

Astigmatism

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

WaveLigh Plus LASIK

Study Details

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

Study ID

NCT07084844

Start date

Sep 5, 2025

Status verified date

Sep, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Study Coordinator

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

Locations

Mann Eye Institute

Recruiting

Houston, Texas, United States, 77004

Contacts

Study Coordinator

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

Principal Investigator:

Phillip Brunson

More Information

Sponsor

Mann Eye Institute

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mann Eye Institute on 2025-09-15.