Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material
- 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
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
Vision North Eye Centre🇨🇦Terrace, British Columbia, Canada