MyopiaNCT07084844
Patient Reported Outcomes With WaveLight Plus LASIK
An observational study of Myopia and Astigmatism, run by Mann Eye Institute 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 to 39 years
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- WaveLigh Plus LASIK
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to 15 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Study population: Eligible test subjects will be 18 to 39 years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism.
Who may be able to join
- Between the ages of 18 and 39
- Meet the standard care requirements for LASIK
- Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters
- Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism
- SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D
- Minimum residual stromal bed thickness of 250 µm
Show all 13Show fewer
- If currently wearing contact lenses:
- Soft CTL wearers discontinue for minimum 3 days
- RGP CTL wearers discontinue for 1 month per decade of wear
- Stable refraction (2 consecutive manifest refractions within 0.25 SE)
- Stable K readings (2 consecutive K readings in 2 consecutive visits)
- Willing and able to complete all post-operative visits
- Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm
Who cannot join
- Subjects with any prior ocular surgery
- Subjects with topographic evidence of keratoconus, or ectasia
- Subjects with autoimmune diseases
- Subjects who are pregnant or nursing
- Systemic disease likely to affect wound healing, such as diabetes and severe atopy
- Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK
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 the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.
- Conditions
- Myopia, Astigmatism
- Being tested
- WaveLigh 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.
WaveLigh 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only).
Measured: 3 months postoperative
Secondary outcomes (3)
PROWL-SS 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. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for 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).
Measured: 3 months postoperative
OSDI Score
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: 3 months postoperative
Uncorrected distance visual acuity
% of eyes in each level of uncorrected visual acuity (e.g. 20/20, 20/16, 20/12.5, 20/10 with logMAR chart).
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start5 Sep 2025
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mann Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Phillip Brunson, Principal investigator, Mann Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084844
- Sponsor's protocol ID
- PB-25-02
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2025
- Last updated
- 5 Oct 2026
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK
- ClinicalTrials.gov ID
- NCT07084844
- Acronym / sponsor ID
- PB-25-02
- Conditions
- Myopia, Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mann Eye InstituteUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 25 Jul 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 the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Eligible test subjects will be 18 to 39 years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism.
Key inclusion criteria (13 listed)
- Between the ages of 18 and 39
- Meet the standard care requirements for LASIK
- Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters
- Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism
- SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D
Key exclusion criteria (6 listed)
- Subjects with any prior ocular surgery
- Subjects with topographic evidence of keratoconus, or ectasia
- Subjects with autoimmune diseases
- Subjects who are pregnant or nursing
- Systemic disease likely to affect wound healing, such as diabetes and severe atopy
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 |
|---|---|---|
| WaveLigh 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 | – |
Primary outcome
Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only).
Time frame: 3 months postoperative
3 secondary outcomes
PROWL-SS Questionnaire
Time frame: 3 months postoperative
OSDI Score
Time frame: 3 months postoperative
Uncorrected distance visual acuity
Time frame: 3 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- 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.
Phillip Brunson principal investigator
Mann Eye Institute
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 Mann Eye Institute 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 13 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 5 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only). (time frame: 3 months postoperative). 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 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.