Cataract
Conditions
Keywords
Toric IOL, Panoptix, multifocal IOL, trifocal IOL
Brief summary
The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric 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 and a quality of life questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.
Interventions
DEVICEPanoptix Toric
Cataract surgery and IOL implantation
Sponsors
Science in Vision
Eye Center of North Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal toric IOL option * Gender: Males and Females. * Age: 40 or older. * Willing and able to provide written informed consent for participation in the study. * Willing and able to comply with scheduled visits and other study procedures. * Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * Have regular corneal astigmatism with a magnitude that can be treated with a toric IOL in the approved range (T3-T6) for the Panoptix lens. * Have 20/32 (0.2 logMAR) or better potential acuity in both eyes
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spectacle independence - emmetropia | 3 months | Percent of patients with ≤ 0.5D of refractive cylinder and ≤ 0.50D of absolute residual spherical equivalent refraction postoperatively who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - a little of the time or none of the time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular uncorrected distance visual acuity | 3 months | Binocular distance visual acuity |
| Binocular uncorrected intermediate visual acuity | 3 months | Binocular intermediate visual acuity |
| BInocular uncorrected near visual acuity | 3 months | Binocular near visual acuity |
| Binocular best-corrected distance visual acuity | 3 months | Binocular best-corrected distance visual acuity |
| Binocular distance-corrected intermediate visual acuity | 3 months | Binocular distance-corrected intermediate visual acuity |
| Binocular distance-corrected near visual acuity | 3 months | Binocular distance-corrected near visual acuity |
| Monocular corrected distance visual acuity | 3 months | Monocular corrected distance visual acuity |
| Residual astigmatism | 3 months | Residual astigmatism |
| Uncorrected preferred reading distance | 3 months | Uncorrected preferred reading distance |
| Spectacle independence - overall | 3 months | Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - a little of the time or none of the time) |
| Binocular uncorrected visual acuity at preferred reading distance | 3 months | Binocular uncorrected visual acuity at preferred reading distance |
| VFQ-14 | 3 months | Questionnaire responses on VFQ-14 visual function questionnaire |
| Choose lens again | 3 months | Percent of patients who would choose this lens modality again. |
| Spherical equivalent refraction | 3 months | Spherical equivalent refraction |
Countries
United States
Outcome results
None listed