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

Terminated
Conditions
Cataract
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.

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
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Percentage of eyes with absolute prediction error less than or equal to 0.50D3 months postoperative
Percentage of eyes with refractive astigmatism less than or equal to 0.50 D3 months postoperative

Trial Locations

Locations (1)

Vision North Eye Centre

🇨🇦

Terrace, British Columbia, Canada

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

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