Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia
NCT04075591 · View on ClinicalTrials.gov ↗
Study Summary
This study will be a 12-month, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation conducted at 8 to 14 sites. A total of 383 subjects will be enrolled to achieve approximately 268 treated subjects, resulting in at least 241 evaluable subjects at the point of refractive stability. After signing the informed consent, subjects meeting all inclusion and exclusion criteria in both eyes may be scheduled for surgery. The follow-up visit schedule will be the same for each operative eye.
Conditions Studied
Interventions
- DEVICE iDesign Refractive Studio with STAR S4 IR® Excimer laser System
Study Locations (10)
Texas
- Berkeley Eye Institute, P.A. — Houston
- Texas Eye & Laser Center — Hurst
California
- Maloney Vision Institute — Los Angeles
Illinois
- Kraff Eye Institute — Chicago
Nevada
- Center for Sight — Las Vegas
New Mexico
- Coleman Vision — Albuquerque
South Dakota
- Vance Thompson Vision — Sioux Falls
Tennessee
- Loden Vision Centers — Goodlettsville
Utah
- Utah Eye Center — Ogden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2019-09-24 |
| Est. Completion | 2025-06-25 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04075591
The ClinicalTrials.gov registry entry for NCT04075591 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AMO Development, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Refractive Error appearing as the primary indexed condition, and to 1 intervention — of which iDesign Refractive Studio with STAR S4 IR® Excimer laser System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04075591 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Texas, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04075591 about?
NCT04075591 is a clinical study titled "Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia". This study will be a 12-month, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation conducted at 8 to 14 sites. A total of 383 subjects will be enrolled to achieve approximately 268 treated subjects, resulting in at least 241 evaluable subjects at the point of...
What is the current status of trial NCT04075591?
This trial is currently completed. It is a NA study. The enrollment target is 219 participants. The study started on 2019-09-24. Estimated completion is 2025-06-25.
What conditions does trial NCT04075591 study?
This clinical trial studies the following conditions: Refractive Error. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04075591?
The interventions under investigation include: iDesign Refractive Studio with STAR S4 IR® Excimer laser System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04075591?
This trial is sponsored by AMO Development, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04075591 being conducted?
This trial has 10 study locations across California, Illinois, Nevada, New Mexico, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.