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

Completed

• Conditions: Cataract
• Interventions: Device: Clareon® IOL AutonoMe™ automated preloaded delivery system

• Registration Number: NCT03824028
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Study Start: 2019-02-10
• Primary Completion: 2020-10-20
• Study Completion: 2020-10-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇯🇵 Hashimoto, Wakayama, Japan