To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) 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 Type
OBSERVATIONAL
Enrollment
30
Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)
Newsom Eye & Laser Center
Sebring, Florida, United States
Binocular Distance-corrected Near (40 cm) Visual Acuity
Time frame: 1 month postoperatively
Binocular Distance-corrected Near (40 cm) Visual Acuity
Time frame: 3 months postoperatively
Binocular Uncorrected Distance (6 m) Visual Acuity
Time frame: 1 and 3 months postoperative
Binocular Uncorrected Intermediate (60 cm) Visual Acuity
Time frame: 1 and 3 months postoperative
Binocular Uncorrected Near (40 cm) Visual Acuity
Time frame: 1 and 3 months postoperative
Binocular Corrected Corrected Distance (6 m) Visual Acuity
Time frame: 1 and 3 months postoperative
Binocular Distance-corrected Intermediate (60 cm) Visual Acuity
Time frame: 1 and 3 months postoperative
Manifest Refraction
spherical equivalent refraction and astigmatism less than or equal to 0.5 D.
Time frame: 3 months postoperative
Satisfaction Questionnaire
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.
Time frame: 3 months postoperative
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Visual Disturbances Questionnaire
Questionnaire for Visual Disturbances (QUVID).
Time frame: 3 months postoperative