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NCT03082599 · ClinicalTrials.gov registry record · NA
Symfony Toric Intraocular Lens Visual Outcomes
A NA study of Astigmatism Bilateral and Cataract Bilateral, sponsored by Carolina Eyecare Physicians.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 4
- Study locations
NCT03082599 is a NA study of Astigmatism Bilateral and Cataract Bilateral that has completed, run by Carolina Eyecare Physicians. The registered enrollment target is 120 participants. The trial reports 4 study locations across 4 states.
The verdict
NCT03082599, a NA study of Astigmatism Bilateral and Cataract Bilateral, has completed, sponsored by Carolina Eyecare Physicians.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 4
- Study locations
Study Summary
In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.
Conditions Studied
Interventions
- DEVICE Presbyopia and astigmatism correcting intraocular lens
Study Locations (4)
Minnesota
- Associated Eye Care - Stillwater
New York
- Ophthalmic Consultants of Long Island - Garden City
South Carolina
- Carolina Eyecare Physicians, LLC - Mt. Pleasant
Texas
- Slade & Baker Vision Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2017-02-17 |
| Est. Completion | 2018-04-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03082599
The ClinicalTrials.gov registry entry for NCT03082599 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carolina Eyecare Physicians, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Astigmatism Bilateral appearing as the primary indexed condition, and to 1 intervention - of which Presbyopia and astigmatism correcting intraocular lens is the first listed.
NCT03082599 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Minnesota, New York, South Carolina.
Frequently Asked Questions
What is clinical trial NCT03082599 about?
NCT03082599 is a clinical study titled "Symfony Toric Intraocular Lens Visual Outcomes". In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric...
What is the current status of trial NCT03082599?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2017-02-17. Estimated completion is 2018-04-03.
What conditions does trial NCT03082599 study?
This clinical trial studies the following conditions: Astigmatism Bilateral, Cataract Bilateral.
What interventions are being tested in trial NCT03082599?
The interventions under investigation include: Presbyopia and astigmatism correcting intraocular lens (DEVICE).
Who is sponsoring clinical trial NCT03082599?
This trial is sponsored by Carolina Eyecare Physicians, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03082599 being conducted?
This trial has 4 study locations across Minnesota, New York, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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