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NCT03170154 · ClinicalTrials.gov registry record · NA
Clinical Investigation of the Clareon® Intraocular Lens (IOL)
A NA study of Cataract, sponsored by Alcon Research.
- Completed
- Registry status
- NA
- Development phase
- 376
- Enrollment target
- 16
- Study locations
NCT03170154: Completed NA study of Cataract, sponsored by Alcon Research.
NCT03170154 is a NA study of Cataract that has completed, run by Alcon Research. The registered enrollment target is 376 participants, above the 224-participant average among 83 other Cataract trials with a reported enrollment target (68% higher). The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03170154, a NA study of Cataract, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 376 participants
- Enrollment target
- 16
- Study locations
Study Summary
The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.
Primary Outcome
Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity o
Conditions Studied
Interventions
- DEVICE Clareon aspheric hydrophobic acrylic monofocal IOL
Study Locations (16)
California
- Alcon Investigative Site - Fresno
- Alcon Investigative Site - Sacramento
- Alcon Investigative Site - San Leandro
New York
- Alcon Investigative Site - New York
- Alcon Investigative Site - Poughkeepsie
North Carolina
- Alcon Investigative Site - Elizabeth City
- Alcon Investigative Site - Southern Pines
South Carolina
- Alcon Investigative Site - Florence
- Alcon Investigative Site - Ladson
Texas
- Alcon Investigative Site - Austin
- Alcon Investigative Site - Nacogdoches
Florida
- Alcon Investigative Site - Deerfield Beach
Illinois
- Alcon Investigative Site - Orland Park
Michigan
- Alcon Investigative Site - Bloomfield Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2017-07-25 |
| Est. Completion | 2019-02-15 |
| Phase | NA |
What the finished NCT03170154 record still lists
NCT03170154 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, above the 224-participant average among 83 other Cataract trials with a reported enrollment target (68% higher).
The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 1 intervention - of which Clareon aspheric hydrophobic acrylic monofocal IOL is the first listed.
NCT03170154 lists 16 locations in 10 states (California, New York, North Carolina).
Frequently Asked Questions
What is clinical trial NCT03170154 about?
NCT03170154 is a clinical study titled "Clinical Investigation of the Clareon® Intraocular Lens (IOL)". The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.
What is the current status of trial NCT03170154?
This trial is currently completed. It is a NA study. The enrollment target is 376 participants. The study started on 2017-07-25. Estimated completion is 2019-02-15.
What conditions does trial NCT03170154 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT03170154?
The interventions under investigation include: Clareon aspheric hydrophobic acrylic monofocal IOL (DEVICE).
Who is sponsoring clinical trial NCT03170154?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03170154 being conducted?
This trial has 16 study locations across California, Florida, Illinois, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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376 12th of 83 higher than 72 of 83 other Cataract trials
participants (enrollment target), bucketed by value
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