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NCT04075591 · ClinicalTrials.gov registry record · NA
Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia
A NA study of Refractive Error, sponsored by AMO Development.
- Completed
- Registry status
- NA
- Development phase
- 219
- Enrollment target
- 10
- Study locations
NCT04075591: Completed NA study of Refractive Error, sponsored by AMO Development.
NCT04075591 is a NA study of Refractive Error that has completed, run by AMO Development. The registered enrollment target is 219 participants, below the 574-participant average among 5 other Refractive Error trials with a reported enrollment target (62% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075591, a NA study of Refractive Error, has completed, sponsored by AMO Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 219 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Change in driving scale score from preoperative to postoperative as measured by driving scale within PROWL-M was reported. PROWL-M driving scale consists of three driving related items that were used to generate the driving scale score. Each item response was converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 (not functioning) and 100 (functioning) points. A high score represents better functioning. The composite driving scale score was calculated by avera
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 |
What the finished NCT04075591 record still lists
NCT04075591 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 574-participant average among 5 other Refractive Error trials with a reported enrollment target (62% lower).
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.
NCT04075591 lists 10 locations in 9 states (Texas, California, Illinois).
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.
What interventions are being tested in trial NCT04075591?
The interventions under investigation include: iDesign Refractive Studio with STAR S4 IR® Excimer laser System (DEVICE).
Who is sponsoring clinical trial NCT04075591?
This trial is sponsored by AMO Development, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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