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Clinical Evaluation of WaveLight Plus LASIK | Clinical Trials | Clareo Health

RECRUITING

Clinical Evaluation of WaveLight Plus LASIK

Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting

NCT07127757•Laser Defined Vision

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 Low Luminance Questionnaire (LLQ-32) Questionnaire.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject must be able to understand and sign an IRB approved Informed consent form
•Willing and able to attend all scheduled study visits as required per protocol
•Minimum of 18 years of age
•Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction
•Best corrected photopic distance visual acuity of 20/20-2 or better (≤ 0.04 logMAR)
•Mesopic pupil size ≥ 4.5mm
•Less than 0.75 D manifest refraction spherical equivalent difference between Sightmap refraction and subjective manifest refraction
•Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery, verified by consecutive subjective refractions or medical records or prescription history
•If currently wearing contact lenses:
•* Soft CTL wearers discontinue for minimum 3 days prior to first refraction
+1 more criteria

Exclusion Criteria

•Subjects who are pregnant or nursing
•Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study
•Patients with flap complications
•Systemic medications that may confound the outcome of the study or increase the risk to the subject.
•Ocular condition (other than high myopia) that may predispose the subject to future complications, such as ectasia
•History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy)
•Evidence of retinal vascular disease
•Keratoconus or Keratoconus suspect
•Glaucoma or glaucoma suspect by exam findings and/or family history
•Previous intraocular or corneal surgery
+3 more criteria

Locations (1)

Laser Defined Vision

Greensboro, North Carolina, United States

Key Dates

Start Date

August 28, 2025

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

October 2, 2025

Enrollment

ESTIMATED participants

Conditions

MyopiaAstigmatism

Interventions

Wavelight Plus LASIK

DEVICE

Contacts

Carrie Williams

CONTACT

336-288-8823 ldv2020@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Evaluation of WaveLight Plus LASIK

Inclusion Criteria

Exclusion Criteria

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