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Completed

NCT Number: NCT03824028

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alcon Investigative Site, Yokohama, Kanagawa, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clareon® IOL AutonoMe™ automated preloaded delivery system

Device

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

Primary outcomes

  1. Best-corrected distance visual acuity

    Time frame: 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.

  2. Intraocular lens (IOL) delivery performance

    Time frame: 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.

  3. Difference between target refraction and postoperative subjective refraction (spherical equivalent)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2019
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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