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

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Status

Completed

Conditions

Cataract

Treatments

Device: Clareon® IOL AutonoMe™ automated preloaded delivery system

Study type

Observational

Funder types

Industry

Identifiers

NCT03824028
ILM171-P001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

384 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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 AutonoMe™.
  • No ophthalmic disease which might affect visual acuity.

Exclusion criteria

  • None.

Trial design

384 participants in 1 patient group

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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