Patient Reported Outcomes With WaveLight LASIK

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-02-14

Brief Summary

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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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Detailed Description

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Conditions

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Myopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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WaveLight® EX500

Phorcidies Planned Contoura LASIK

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No