Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material

NCT ID: NCT05488769

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2022-11-29

Brief Summary

The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.

Detailed Description

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Clareon Vivity extended depth of focus (EDOF) intraocular lens

Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens

Clareon Vivity extended depth of focus (EDOF) intraocular lens

Intervention Type: DEVICE

Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens

Interventions

Clareon Vivity extended depth of focus (EDOF) intraocular lens

Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Note: Ocular criteria must be met in both eyes.

• Visually significant age-related cataracts bilaterally.
• Best monocular Corrected distance Visual Acuity predicted to be (20/25) or better after cataract removal and IOL implantation as determined by surgeon.
• Gender: Males and Females.
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visits and other study procedures.
• Clear intraocular media other than cataract.
• Planned Bilateral implantation of the Clareon Vivity and Vivity toric IOLs.
• IOL powers between 6D and 30D, T2-T6.

Exclusion Criteria

• Previous ocular or refractive surgery
• Ocular surface disease/Dry Eye Disease
• Intraoperative complications during procedure
• Glaucoma, including well-controlled
• Any disorders that reduce binocular vision (ie Strabismus)
• Any ocular comorbidity that, in the opinion of the investigator reduce post-op visual acuity (e.g. AMD etc)

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Thomas Nagy

OTHER

Sponsor Role: lead

Responsible Party

Thomas Nagy

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas Nagy, MD

Role: PRINCIPAL_INVESTIGATOR

Vision North Eye Centre

Locations

Vision North Eye Centre

Terrace, British Columbia, Canada

Countries

Canada

Other Identifiers

TN-22-001

Identifier Type: -

Identifier Source: org_study_id