Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Thomas Nagy
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Binocular distance-corrected visual acuity at distance (6m)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Thomas Nagy
Principal Investigator
Vision North Eye Centre
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Binocular distance-corrected visual acuity at distance (6m)
Time Frame: 3 months postoperative
Binocular distance-corrected visual acuity at intermediate (66cm)
Time Frame: 3 months postoperative
Secondary Outcomes
- 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)