MyopiaNCT07127757
Clinical Evaluation of WaveLight Plus LASIK
An observational study of Myopia and Astigmatism, run by Laser Defined Vision at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Wavelight Plus LASIK
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Eligible test subjects will be 18+ years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism. Patients who are eligible for LASIK surgery with the Wavelight Plus device may undergo the procedure even if they choose not to participate in the research study. The decision to perform surgery with the device will be made based on clinical indications, irrespective of participation in the study.
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Laser Defined Vision
Greensboro, North Carolina, 27401
Carrie Willams, 336-288-8823, ldv2020@gmail.com
Karl Stonecipher, MD
About this study
Official title: Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting
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
- Being tested
- Wavelight Plus LASIK
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavelight Plus LASIKDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wavelight Plus LASIK | Not described Receives: Device: Wavelight Plus LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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: 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)
Measured: 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)
Measured: 3 months postoperatively
Secondary outcomes (5)
% of eyes that achieve UDVA equal to or better than preoperative CDVA
Measured: 3 months postoperatively
% of eyes with lines gained/lost lines (post-up UDVA VS pre-op CDVA)
Measured: 3 months postoperatively
% of eyes with absolute MRSE within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months
Measured: 3 months postoperatively
% of eyes that achieved manifest refraction cylinder within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months
Measured: 3 months postoperatively
Patient-Reported Outcomes with the modified PROWL Questionnaire and Low Luminance Questionnaire (LLQ-32) at 3 months
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start28 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laser Defined Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Karl Stonecipher, MD, Principal investigator, Laser Defined Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127757
- Sponsor's protocol ID
- KS-25-01
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting
- ClinicalTrials.gov ID
- NCT07127757
- Acronym / sponsor ID
- KS-25-01
- Conditions
- Myopia, Astigmatism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Laser Defined VisionUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wavelight Plus LASIK | – | Device: Wavelight Plus LASIK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible test subjects will be 18+ years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism. Patients who are eligible for LASIK surgery with the Wavelight Plus device may undergo the procedure even if they choose not to participate in the research study. The decision to perform surgery with the device will be made based on clinical indications, irrespective of participation in the study.
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wavelight Plus LASIKWavelight 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. | Device | Wavelight Plus LASIK |
Primary outcome
% 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
5 secondary outcomes
% of eyes that achieve UDVA equal to or better than preoperative CDVA
Time frame: 3 months postoperatively
% of eyes with lines gained/lost lines (post-up UDVA VS pre-op CDVA)
Time frame: 3 months postoperatively
% of eyes with absolute MRSE within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months
Time frame: 3 months postoperatively
% of eyes that achieved manifest refraction cylinder within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months
Time frame: 3 months postoperatively
Patient-Reported Outcomes with the modified PROWL Questionnaire and Low Luminance Questionnaire (LLQ-32) at 3 months
Time frame: 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karl Stonecipher, MD principal investigator
Laser Defined Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Astigmatism, run by Laser Defined Vision at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie Williams (336-288-8823, ldv2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.