NCT07127757 Clinical Evaluation of WaveLight Plus LASIK
| NCT ID | NCT07127757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laser Defined Vision |
| Condition | Myopia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-08-28 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Karl Stonecipher, MD
PRINCIPAL INVESTIGATOR
Laser Defined Vision
Frequently Asked Questions
Who can join the NCT07127757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07127757 currently recruiting?
Yes, NCT07127757 is actively recruiting participants. Contact the research team at ldv2020@gmail.com for enrollment information.
Where is the NCT07127757 trial being conducted?
This trial is being conducted at Greensboro, United States.
Who is sponsoring the NCT07127757 clinical trial?
NCT07127757 is sponsored by Laser Defined Vision. The principal investigator is Karl Stonecipher, MD at Laser Defined Vision. The trial plans to enroll 50 participants.