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

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT03824028

Collaborator

(none)

384

Enrollment

Locations

20.3

Actual Duration (Months)

128

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Clareon® IOL AutonoMe™ automated preloaded delivery system

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 Design

Study Type:

Observational

Actual Enrollment :

384 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 10, 2019

Actual Primary Completion Date :

Oct 20, 2020

Actual Study Completion Date :

Oct 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Clareon IOL AutonoMe Prior implantation with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system	Device: Clareon® IOL AutonoMe™ automated preloaded delivery system Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery

Arm

Intervention/Treatment

Clareon IOL AutonoMe

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

Device: Clareon® IOL AutonoMe™ automated preloaded delivery system

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Yokohama	Kanagawa	Japan	220-0011
2	Alcon Investigative Site	Yokkaichi	Mie	Japan	510-0085
3	Alcon Investigative Site	Hashimoto	Wakayama	Japan	648-0073