Clinical Evaluation of WaveLight Plus LASIK for Myopia and Astigmatism

This study is looking at how well WaveLight Plus LASIK works for people with nearsightedness (myopia) and astigmatism (blurry vision due to an imperfectly shaped eye). WaveLight Plus LASIK is an advanced laser eye surgery that creates a personalized treatment plan for each person. Researchers want to see how satisfied people are with their vision, their quality of vision, and their quality of life after this surgery. They will measure how clearly people can see in different lighting conditions three months after surgery. You might be able to join if you are at least 18 years old and have myopia up to -8.00 D and astigmatism up to -3.00 D. The current recruitment status is unclear.

Study design: This is an observational study involving 50 participants at a single location. It is a single-arm study, meaning everyone receives the WaveLight Plus LASIK intervention.
What's involved: You would attend scheduled study visits and have clinical evaluations, including vision tests and questionnaires, for up to 3 months after surgery.
Compensation: Not stated in the trial record.
Follow-up: Participants will be assessed for up to 3 months after their surgery, with primary measurements taken at 3 months post-operatively.

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Clinical Evaluation of WaveLight Plus LASIK

Recruiting

Not specifiedAges 18+Observational

Laser Defined Vision

~50 participants

Updated 2025-10-02 on ClinicalTrials.gov

What's tested:Wavelight Plus LASIK

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

% of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular)

Measured over 3 months postoperatively

+2 more outcomes measured

Conditions

Myopia

Astigmatism

Where it's being run

1 sites across 1 states

North Carolina1

Study leadership

Karl Stonecipher, MD · PRINCIPAL_INVESTIGATOR · Laser Defined Vision

Who to contact

Carrie Williams

[email protected]

336-288-8823

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

RGP or toric soft CTL wearers discontinue for ≥2 weeks prior to first refraction

Exclusion

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

Predicted residual stromal bed thickness \< 250 μm

Intended to have monovision treatment

Participation in other current clinical trials

What this trial measures

% of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular)3 months postoperatively
% of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in mesopic conditions at 3 months (monocular and binocular)3 months postoperatively
% of eyes with CDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular)3 months postoperatively

Trialytics