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NCT03280108 · ClinicalTrials.gov registry record · NA
Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
A NA study of Cataract, sponsored by Alcon Research.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 12
- Study locations
NCT03280108: Completed NA study of Cataract, sponsored by Alcon Research.
NCT03280108 is a NA study of Cataract that has completed, run by Alcon Research. The registered enrollment target is 250 participants, above the 225-participant average among 83 other Cataract trials with a reported enrollment target (11% higher). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03280108, a NA study of Cataract, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.
Primary Outcome
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. T
Conditions Studied
Interventions
- DEVICE AcrySof IQ PanOptix Multifocal IOL
- DEVICE AcrySof Monofocal IOL
Study Locations (12)
Texas
- Alcon Investigative Site - Houston
- Alcon Investigative Site - Hurst
- Alcon Investigative Site - Nacogdoches
Florida
- Alcon Investigative Site - Mt. Dora
- Alcon Investigative Site - Panama City
California
- Alcon Investigative Site - Fresno
New York
- Alcon Investigative Site - Poughkeepsie
South Carolina
- Alcon Investigative Site - Mt. Pleasant
South Dakota
- Alcon Investigative Site - Sioux Falls
Tennessee
- Alcon Investigative Site - Nashville
Utah
- Alcon Investigative Site - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2018-09-27 |
| Phase | NA |
What the finished NCT03280108 record still lists
NCT03280108 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 225-participant average among 83 other Cataract trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 2 interventions - of which AcrySof IQ PanOptix Multifocal IOL is the first listed.
NCT03280108 lists 12 locations in 9 states (Texas, Florida, California).
Frequently Asked Questions
What is clinical trial NCT03280108 about?
NCT03280108 is a clinical study titled "Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00". The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermedia...
What is the current status of trial NCT03280108?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2017-11-01. Estimated completion is 2018-09-27.
What conditions does trial NCT03280108 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT03280108?
The interventions under investigation include: AcrySof IQ PanOptix Multifocal IOL (DEVICE), AcrySof Monofocal IOL (DEVICE).
Who is sponsoring clinical trial NCT03280108?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03280108 being conducted?
This trial has 12 study locations across California, Florida, New York, South Carolina, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03280108's enrollment target sits among peer trials
250 21st of 83 higher than 62 of 83 other Cataract trials
participants (enrollment target), bucketed by value
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