Evaluation of Quality of Vision and Spectacle Independence With Bilateral Implantation of the AcrySof® Panoptix® Intraocular Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- SightTrust Eye Institute
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Emmetropic Subjects Who Are Spectacle Independent
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a study to assess the spectacle independence and quality of vision of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.
Detailed Description
This study is a single-arm unmasked clinical evaluation study of spectacle independence 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 spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Emmetropic Subjects Who Are Spectacle Independent
Time Frame: 3 months
Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time").
Secondary Outcomes
- Binocular Uncorrected Distance Visual Acuity(3 months)
- Binocular Uncorrected Intermediate Visual Acuity(3 months)
- Binocular Uncorrected Near Visual Acuity(3 months)
- Residual Refractive Cylinder(3 months)
- Binocular Corrected Distance Visual Acuity(3 months)
- Binocular Distance-corrected Near Visual Acuity(3 months)
- Spherical Equivalent Refraction(3 months)
- Quality of Vision Questionnaire(3 months)
- Overall Spectacle Independence(3 months)
- Binocular Distance-corrected Intermediate Visual Acuity(3 months)