Post-Market Clinical Survey of Clareon® IOL AutonoMe™ in Japanese Subjects

NCT ID: NCT03824028

Last Updated: 2021-03-10

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

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-10

Study Completion Date

2020-10-20

Brief Summary

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This purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice.

Detailed Description

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This study will enroll subjects who underwent prior cataract surgery with phacoemulsification and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system. Subjects will be enrolled post-operatively and followed for one year.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clareon IOL AutonoMe

Prior implantation with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system

Clareon® IOL AutonoMe™ automated preloaded delivery system

Intervention Type DEVICE

Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery

Interventions

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Clareon® IOL AutonoMe™ automated preloaded delivery system

Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Able to comprehend and willing to sign informed consent.
* Prior diagnosis of age-related cataracts.
* Prior cataract surgery with implantation of Clareon IOL in the capsular bag by AutonoMeâ„¢.
* No ophthalmic disease which might affect visual acuity.

Exclusion Criteria

* None.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alcon Research

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Locations

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Alcon Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Alcon Investigative Site

Yokkaichi, Mie-ken, Japan

Site Status

Alcon Investigative Site

Hashimoto, Wakayama, Japan

Site Status

Countries

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Japan

References

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Oshika T, Sasaki N; Clinical Study Group on New Intraocular Lens and Delivery System. One-year multicenter evaluation of a new hydrophobic acrylic intraocular lens with hydroxyethyl methacrylate in an automated preloaded delivery system. J Cataract Refract Surg. 2022 Mar 1;48(3):275-279. doi: 10.1097/j.jcrs.0000000000000746.

Reference Type DERIVED
PMID: 34261986 (View on PubMed)

Other Identifiers

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ILM171-P001

Identifier Type: -

Identifier Source: org_study_id

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