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NCT03372434 · ClinicalTrials.gov registry record · NA
Clinical Investigation of the Next-Generation Intraocular Lenses
A NA study of Cataract, sponsored by Abbott Medical Optics.
- Completed
- Registry status
- NA
- Development phase
- 225
- Enrollment target
- 12
- Study locations
NCT03372434: Completed NA study of Cataract, sponsored by Abbott Medical Optics.
NCT03372434 is a NA study of Cataract that has completed, run by Abbott Medical Optics. The registered enrollment target is 225 participants, roughly in line with the 226-participant average among 83 other Cataract trials with a reported enrollment target. The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03372434, a NA study of Cataract, has completed, sponsored by Abbott Medical Optics.
- COMPLETED
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.
Primary Outcome
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Conditions Studied
Interventions
- DEVICE Investigational Intraocular Lens Device #1: Model ZFR00
- DEVICE Investigational Intraocular Lens Device #1: Model ZYR00
- DEVICE TECNIS Multifocal Intraocular Lens: Model ZLB00
Study Locations (12)
Texas
- Texas Eye and Laser Center - Hurst
- Lehmann Eye Center - Nacogdoches
- Focal Point Vision - San Antonio
Maryland
- Chesapeake Eye Care & Laser Center - Annapolis
- Eye Doctors of Washington - Chevy Chase
Tennessee
- Loden Vision Centers - Goodlettsville
- Eye Specialty Group - Memphis
California
- Empire Eye & Laser Center - Bakersfield
Florida
- Katzen Eye Care and Laser Center - Boynton Beach
Pennsylvania
- Scott & Christie and Associates, PC - Cranberry Township
South Carolina
- Carolina EyeCare Physicians, LLC - Mt. Pleasant
Washington
- Clarus Eye Centre - Lacey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2018-01-16 |
| Est. Completion | 2018-10-30 |
| Phase | NA |
What the finished NCT03372434 record still lists
NCT03372434 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 226-participant average among 83 other Cataract trials with a reported enrollment target.
The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 3 interventions - of which Investigational Intraocular Lens Device #1: Model ZFR00 is the first listed.
NCT03372434 lists 12 locations in 8 states (Texas, Maryland, Tennessee).
Frequently Asked Questions
What is clinical trial NCT03372434 about?
NCT03372434 is a clinical study titled "Clinical Investigation of the Next-Generation Intraocular Lenses". This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. The study will be conducted at up to 14 sites in the U.S.A a...
What is the current status of trial NCT03372434?
This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2018-01-16. Estimated completion is 2018-10-30.
What conditions does trial NCT03372434 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT03372434?
The interventions under investigation include: Investigational Intraocular Lens Device #1: Model ZFR00 (DEVICE), Investigational Intraocular Lens Device #1: Model ZYR00 (DEVICE), TECNIS Multifocal Intraocular Lens: Model ZLB00 (DEVICE).
Who is sponsoring clinical trial NCT03372434?
This trial is sponsored by Abbott Medical Optics, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03372434 being conducted?
This trial has 12 study locations across California, Florida, Maryland, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03372434's enrollment target sits among peer trials
225 24th of 83 higher than 60 of 83 other Cataract trials
participants (enrollment target), bucketed by value
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