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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 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.

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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.

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

FieldValue
Enrollment Target 453 participants
Start Date 2018-12-04
Est. Completion 2020-10-15
Phase NA

Sponsor

AcuFocus

4 total trials

What the Registry Record Tells You About NCT03633695

The ClinicalTrials.gov registry entry for NCT03633695 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 453 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 223-participant average among 83 other Cataract trials with a reported enrollment target (103% higher). The listed sponsor is AcuFocus, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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