MyopiaNCT06668909
Patient Reported Outcomes With WaveLight LASIK
An observational study of Myopia, run by OVO LASIK + Lens at 4 sites in United States.
Trial summary
This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires. Read more about this study
- Who is it for?
- Ages 21 to 35 years
- Conditions the study is for
- Myopia
- What is being tested?
- WaveLight® EX500
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2024to 14 Feb 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 35 years
- All sexes
- Adult
Study population: Eligible test subjects will be 21 to 35 years of age (at the time of surgery) and who underwent Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months prior.
Who may be able to join
- Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months ago
- Age: 21 to 35 years of age at the time of surgery.
- Preoperative myopic sphere of -1.00 D to -8.00 D
- Preoperative regular astigmatism of 0.00 D to -3.00 D.
- Stable refraction preoperatively defined as < 0.5 D of change over at least 1 year.
- Refractive target of bilateral emmetropia.
Who cannot join
- Corneal ectatic disorders.
- Patients with a calculated residual stromal depth of < 300 um.
- Pre-existing retinal or corneal pathology, or irregular astigmatism.
- Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc.
- Previous corneal surgeries prior to LASIK.
- LASIK enhancements.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston Vision
Brookline, Massachusetts, 02445
Mann Eye Institute
Houston, Texas, 76134-2099
Ovo Lasik + Lens
Saint Louis Park, Minnesota, 55416
NVISION Eye Centers
San Diego, California, 92130
About this study
Official title: Patient Reported Outcomes on Vision Quality and Dry Eye Following Treatment With Wavelight LASIK
This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.
- Conditions
- Myopia
- Being tested
- WaveLight® EX500
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaveLight® EX500Device
Phorcidies Planned Contoura LASIK
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).
Measured: 12 months postoperatively
Secondary outcomes (3)
PROWL Questionnaire
PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question.
Measured: 12 months postoperatively
OSDI Questionnaire
The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Measured: 12 months postoperatively
Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Nov 2024
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- OVO LASIK + Lens
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668909
- Sponsor's protocol ID
- ML-24-01
- Status last verified
- Mar 2026
- First submitted
- 30 Oct 2024
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes on Vision Quality and Dry Eye Following Treatment With Wavelight LASIK
- ClinicalTrials.gov ID
- NCT06668909
- Acronym / sponsor ID
- ML-24-01
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- OVO LASIK + LensUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Posted 23 Mar 2026
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 multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- Eligible test subjects will be 21 to 35 years of age (at the time of surgery) and who underwent Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months prior.
Key inclusion criteria (6 listed)
- Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months ago
- Age: 21 to 35 years of age at the time of surgery.
- Preoperative myopic sphere of -1.00 D to -8.00 D
- Preoperative regular astigmatism of 0.00 D to -3.00 D.
- Stable refraction preoperatively defined as < 0.5 D of change over at least 1 year.
Key exclusion criteria (6 listed)
- Corneal ectatic disorders.
- Patients with a calculated residual stromal depth of < 300 um.
- Pre-existing retinal or corneal pathology, or irregular astigmatism.
- Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc.
- Previous corneal surgeries prior to LASIK.
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® EX500Phorcidies Planned Contoura LASIK | Device | – |
Primary outcome
Patient Satisfaction
Time frame: 12 months postoperatively
Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).
3 secondary outcomes
PROWL Questionnaire
Time frame: 12 months postoperatively
OSDI Questionnaire
Time frame: 12 months postoperatively
Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication.
Time frame: 12 months postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by OVO LASIK + Lens at 4 sites 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 12 months postoperatively). 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 23 Mar 2026.