Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
52 participants
OBSERVATIONAL
2025-09-05
2026-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Patient Reported Outcomes With WaveLight LASIK
NCT06668909
Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software
NCT05848817
A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
NCT07201298
SMILE vs. LASIK Using Contoura With Phorcides
NCT05844397
Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery
NCT07078799
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
WaveLigh 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
39 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sengi
INDUSTRY
Mann Eye Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Phillip Brunson
Role: PRINCIPAL_INVESTIGATOR
Mann Eye Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mann Eye Institute
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PB-25-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.