Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

NCT ID: NCT05758883

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-12

Study Completion Date

2024-02-16

Brief Summary

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The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

Detailed Description

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A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.

Conditions

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Cataract Presbyopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IC-8 Apthera intraocular lens (IOL) Group

Patients previously enrolled in the IC-8 Apthera IOL Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
* Able to comprehend and have signed a statement of informed consent
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AcuFocus, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center

Tucson, Arizona, United States

Site Status

Empire Eye & Laser Center

Bakersfield, California, United States

Site Status

Harvard Eye Associates

Laguna Hills, California, United States

Site Status

Altos Eye Physicians

Los Altos, California, United States

Site Status

Advanced Vision Care

Los Angeles, California, United States

Site Status

Eye Center of Northern Colorado

Fort Collins, Colorado, United States

Site Status

Chu Vision Institute

Bloomington, Minnesota, United States

Site Status

Pepose Vision Institute

St Louis, Missouri, United States

Site Status

Kugler Vision

Omaha, Nebraska, United States

Site Status

Alterman, Modi & Wolter

Poughkeepsie, New York, United States

Site Status

Physicians Protocol

Greensboro, North Carolina, United States

Site Status

Cleveland Eye Clinic

Brecksville, Ohio, United States

Site Status

Philadelphia Eye Associates

Philadelphia, Pennsylvania, United States

Site Status

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, United States

Site Status

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Parkhurst NuVision

San Antonio, Texas, United States

Site Status

Hoopes Vision

Draper, Utah, United States

Site Status

Utah Eye Centers

Ogden, Utah, United States

Site Status

Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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SAIL-101-PAS

Identifier Type: -

Identifier Source: org_study_id

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