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Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

NCT03633695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2022-10-24

Study results available
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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

Interventions

DEVICE

IC-8 IOL Group

A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.

DEVICE

Control Group

A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.

Sponsors & Collaborators

  • AcuFocus, Inc.

    lead INDUSTRY

Principal Investigators

  • Magda Michna, PhD · AcuFocus, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2020-10-15
Completion
2020-10-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633695 on ClinicalTrials.gov