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

Post-Market Clinical Survey of Clareon® IOL With the AutonoMe™ Automated Preloaded Delivery System With Japanese Subjects

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03824028

Enrollment

384

Registered

2019-01-31

Start date

2019-02-10

Completion date

2020-10-20

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Cataract surgery, Intraocular lens, IOL, Clareon, AutonoMe

Brief summary

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

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.

Interventions

DEVICEClareon® IOL AutonoMe™ automated preloaded delivery system

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Best-corrected distance visual acuity	Up to Year 1 postoperative	Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart.
Intraocular lens (IOL) delivery performance	Surgery day (retrospective)	A questionnaire will be used to retrospectively evaluate the usability of AutonoME™. The investigator will respond to 8 questions pertaining to the IOL delivery performance using a 5-point scale where 1 = very good/strongly agree and 5 = very poor/strongly disagree.
Difference between target refraction and postoperative subjective refraction (spherical equivalent)	Up to Year 1 postoperative	Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. Subjective refraction at best corrected distance vision will be recorded and compared with target refraction determined on day of surgery.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026