Refractive Assessment
Conditions
Keywords
Vivity, Extended Vision Toric Intraocular Lens, Patient satisfaction and visual outcomes
Brief summary
The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.
Detailed description
To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.
Interventions
OTHERProcedure: Vivity Toric IOL
The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's Vivity Toric Extended Vision intraocular lens (IOL) for cataract patients. This innovative lens is an extended depth of focus IOL that has been reported to result in fewer visual disturbances than diffractive IOLs.
Sponsors
Alcon Research
Icon Eye Care
EVP Eye Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Subjects to receive bilateral implantation of Vivity Extended Vision Toric Intraocular Lens
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6 * Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit * Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator
Exclusion criteria
* Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity * Ocular trauma or zonular weakness/instability * Diagnosis of glaucoma or high-risk glaucoma suspect * Previous refractive surgery * Unreliable preoperative biometry measurements * Severe dry eye or ocular surface disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular best distance-corrected near visual acuity | 4 months | Binocular best distance-corrected near visual acuity |
| Monocular visual acuity at distance | 4 months | Monocular uncorrected distance visual acuity |
| Binocular visual acuity at distance | 4 months | Binocular uncorrected distance visual acuity |
| Monocular best corrected distance visual acuity | 4 months | Monocular best corrected distance visual acuity |
| Binocular best corrected distance visual acuity | 4 months | Binocular best corrected distance visual acuity |
| Monocular best distance-corrected intermediate visual acuity | 4 months | Monocular best distance-corrected intermediate visual acuity |
| Binocular best distance-corrected intermediate visual acuity | 4 months | Binocular best distance-corrected intermediate visual acuity |
| Monocular best distance-corrected near visual acuity | 4 months | Monocular best distance-corrected near visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual refractive cylinder | 4 months | Manifest postoperative refractive cylinder (measured in diopters, with a phoropter) after cataract surgery and IOL implantation. |
Countries
United States
Outcome results
None listed