Recruiting

LASIK

Sponsor:

Laser Defined Vision

Code:

NCT07127757

Conditions

Myopia

Astigmatism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wavelight Plus LASIK

Study Details

Brief 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.

Conditions

Myopia

Astigmatism

Study ID

NCT07127757

Start date

Aug 28, 2025

Status verified date

Sep, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

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
  • Predicted residual stromal bed thickness < 250 μm
  • Intended to have monovision treatment
  • Participation in other current clinical trials

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Wavelight Plus LASIK

Interventions

Wavelight Plus LASIK

Wavelight plus LASIK is an advanced laser eye surgery technology designed to enhance visual outcomes through personalized treatment plans. This system integrates comprehensive diagnostics, including biometry, tomography, and wavefront measurements, to create a tailored ablation profile for each patient.

Primary outcome measure

  • % of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Central contacts

Carrie Williams

336-288-8823ldv2020@gmail.com

Locations

Laser Defined Vision

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Carrie Willams

336-288-8823ldv2020@gmail.com

Principal Investigator:

Karl Stonecipher, MD

More Information

Sponsor

Laser Defined Vision

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Laser Defined Vision on 2025-10-02.