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NCT03274986 · ClinicalTrials.gov registry record · NA
A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)
A NA study of Cataract, sponsored by Alcon Research.
- Completed
- Registry status
- NA
- Development phase
- 242
- Enrollment target
- 11
- Study locations
NCT03274986: Completed NA study of Cataract, sponsored by Alcon Research.
NCT03274986 is a NA study of Cataract that has completed, run by Alcon Research. The registered enrollment target is 242 participants, roughly in line with the 225-participant average among 83 other Cataract trials with a reported enrollment target. The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03274986, a NA study of Cataract, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 242 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.
Primary Outcome
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. Th
Conditions Studied
Interventions
- PROCEDURE Cataract surgery
- DEVICE ACRYSOF® IQ Extended Depth of Focus IOL
- DEVICE ACRYSOF® IQ Monofocal IOL
Study Locations (11)
Pennsylvania
- Alcon Investigative Site - Allenwood
- Alcon Investigative Site - Kingston
- Alcon Investigative Site - West Mifflin
Florida
- Alcon Investigative Site - Bradenton
- Alcon Investigative Site - Sebring
Alabama
- Alcon Investigative Site - Birmingham
Colorado
- Alcon Investigative Site - Fort Collins
Georgia
- Alcon Investigative Site - Gainesville
Illinois
- Alcon Investigative Site - Rock Island
Ohio
- Alcon Investigative Site - Cincinnati
South Dakota
- Alcon Investigative Site - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2018-10-16 |
| Phase | NA |
What the finished NCT03274986 record still lists
NCT03274986 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 225-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 Cataract surgery is the first listed.
NCT03274986 lists 11 locations in 8 states (Pennsylvania, Florida, Alabama).
Frequently Asked Questions
What is clinical trial NCT03274986 about?
NCT03274986 is a clinical study titled "A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)". The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF ...
What is the current status of trial NCT03274986?
This trial is currently completed. It is a NA study. The enrollment target is 242 participants. The study started on 2017-10-11. Estimated completion is 2018-10-16.
What conditions does trial NCT03274986 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT03274986?
The interventions under investigation include: Cataract surgery (PROCEDURE), ACRYSOF® IQ Extended Depth of Focus IOL (DEVICE), ACRYSOF® IQ Monofocal IOL (DEVICE).
Who is sponsoring clinical trial NCT03274986?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03274986 being conducted?
This trial has 11 study locations across Alabama, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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