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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824028
• Other study ID #: ILM171-P001
• Status: Completed
• Start date: February 10, 2019
• Est. completion date: October 20, 2020

Study information

• Verified date: March 2021
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: October 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Clareon® IOL AutonoMe™ automated preloaded delivery system
Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery

Locations

Country	Name	City	State
Japan	Alcon Investigative Site	Hashimoto	Wakayama
Japan	Alcon Investigative Site	Yokkaichi	Mie
Japan	Alcon Investigative Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected distance visual acuity	Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart.	Up to Year 1 postoperative
Primary	Intraocular lens (IOL) delivery performance	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.	Surgery day (retrospective)
Primary	Difference between target refraction and postoperative subjective refraction (spherical equivalent)	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.	Up to Year 1 postoperative