Patient Reported Outcomes With WaveLight Plus LASIK

Mann Eye Institute

Status: Enrolling

Conditions: Myopia; Astigmatism

Treatments: Device: WaveLigh Plus LASIK

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07084844

PB-25-02

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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