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OpenTrials
Completed

NCT Number: NCT06668909

Patient Reported Outcomes With WaveLight LASIK

This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NVISION Eye Centers, San Diego, California, United States

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months ago
  • Age: 21 to 35 years of age at the time of surgery.
  • Preoperative myopic sphere of -1.00 D to -8.00 D
  • Preoperative regular astigmatism of 0.00 D to -3.00 D.
  • Stable refraction preoperatively defined as < 0.5 D of change over at least 1 year.
  • Refractive target of bilateral emmetropia.

Exclusion criteria

  • Corneal ectatic disorders.
  • Patients with a calculated residual stromal depth of < 300 um.
  • Pre-existing retinal or corneal pathology, or irregular astigmatism.
  • Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc.
  • Previous corneal surgeries prior to LASIK.
  • LASIK enhancements.

Treatment and study plan

WaveLight® EX500

Device

Phorcidies Planned Contoura LASIK

Primary outcomes

  1. Patient Satisfaction

    Time frame: 12 months postoperatively

    Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).

Secondary outcomes

  1. PROWL Questionnaire

    Time frame: 12 months postoperatively

    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.

  2. OSDI Questionnaire

    Time frame: 12 months postoperatively

    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. Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication.

    Time frame: 12 months postoperatively

Sponsors and collaborators

Lead sponsor

OVO LASIK + Lens

Other

Collaborators

  • Sengi

Registry information

Official study title

Patient Reported Outcomes on Vision Quality and Dry Eye Following Treatment With Wavelight LASIK

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Mar 23, 2026

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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