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

Terminated

• Conditions: Cataract
• Interventions: Device: Clareon Vivity extended depth of focus (EDOF) intraocular lens

• Registration Number: NCT05488769
• Lead Sponsor: Thomas Nagy

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.

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2022-08-25
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Binocular distance-corrected visual acuity at distance (6m)	3 months postoperative
Binocular distance-corrected visual acuity at intermediate (66cm)	3 months postoperative

Secondary Outcome Measures

Name	Time	Method
Percentage of eyes with absolute prediction error less than or equal to 0.50D	3 months postoperative
Percentage of eyes with refractive astigmatism less than or equal to 0.50 D	3 months postoperative

Trial Locations

Locations (1)

Vision North Eye Centre; 🇨🇦 Terrace, British Columbia, Canada