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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03824028
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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
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
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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 : February 10, 2019
Actual Primary Completion Date : October 20, 2020
Actual Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be enrolled at approximately 20 investigative sites located in Japan.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824028


Locations
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Japan
Alcon Investigative Site
Yokohama, Kanagawa, Japan, 220-0011
Alcon Investigative Site
Yokkaichi, Mie, Japan, 510-0085
Alcon Investigative Site
Hashimoto, Wakayama, Japan, 648-0073
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon Research Alcon Japan, Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03824028    
Other Study ID Numbers: ILM171-P001
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alcon Research:
Cataract surgery
Intraocular lens
IOL
Clareon
AutonoMe
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases