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NCT03633695 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
A NA study of Cataract and Presbyopia, sponsored by AcuFocus.
- Completed
- Registry status
- NA
- Development phase
- 453
- Enrollment target
- 20
- Study locations
NCT03633695: Completed NA study of Cataract and Presbyopia, sponsored by AcuFocus.
NCT03633695 is a NA study of Cataract and Presbyopia that has completed, run by AcuFocus. The registered enrollment target is 453 participants, above the 223-participant average among 83 other Cataract trials with a reported enrollment target (103% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03633695, a NA study of Cataract and Presbyopia, has completed, sponsored by AcuFocus.
- COMPLETED
- Registry status
- NA
- Development phase
- 453 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.
Primary Outcome
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Conditions Studied
Interventions
- DEVICE Control Group
- DEVICE IC-8 IOL Group
Study Locations (20)
California
- Empire Eye & Laser Center - Bakersfield
- Harvard Eye Associates - Laguna Hills
- Altos Eye Physicians - Los Altos
- Advanced Vision Care - Los Angeles
Pennsylvania
- Philadelphia Eye Associates - Philadelphia
- Bucci Laser Vision - Wilkes-Barre
Texas
- Baylor College of Medicine - Houston
- Parkhurst NuVision - San Antonio
Utah
- Hoopes Vision - Draper
- Utah Eye Centers - Ogden
Arizona
- Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center - Tucson
Colorado
- Eye Center of Northern Colorado - Fort Collins
Florida
- Eye Center of North Florida - Panama City
Minnesota
- Chu Vision Institute - Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2018-12-04 |
| Est. Completion | 2020-10-15 |
| Phase | NA |
What the finished NCT03633695 record still lists
NCT03633695 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, above the 223-participant average among 83 other Cataract trials with a reported enrollment target (103% higher).
The record links to 2 conditions, with Cataract appearing as the primary indexed condition, and to 2 interventions - of which Control Group is the first listed.
NCT03633695 names 20 study sites across 14 states, led by California, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT03633695 about?
NCT03633695 is a clinical study titled "Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens". The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.
What is the current status of trial NCT03633695?
This trial is currently completed. It is a NA study. The enrollment target is 453 participants. The study started on 2018-12-04. Estimated completion is 2020-10-15.
What conditions does trial NCT03633695 study?
This clinical trial studies the following conditions: Cataract, Presbyopia.
What interventions are being tested in trial NCT03633695?
The interventions under investigation include: Control Group (DEVICE), IC-8 IOL Group (DEVICE).
Who is sponsoring clinical trial NCT03633695?
This trial is sponsored by AcuFocus, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03633695 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03633695's enrollment target sits among peer trials
453 7th of 83 higher than 77 of 83 other Cataract trials
participants (enrollment target), bucketed by value
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