Cataract Surgery, Correction Vision Surgery
Conditions
Brief summary
Millions of people have undergone laser vision correction surgery and are motivated to continue with spectacle independence as they develop presbyopia (gradual loss of your eyes' ability to focus on nearby objects)and cataract. However, having a history of refractive surgery, poses challenges in the selection of the IOLs and can lead to visual outcomes that are unpredictable. Data from an international registry and single prospective study show that Vivity IOL provided effective distance, intermediate and near vision in eyes with previous LASIK with minimal effects on day vision associated with the surgery. The purpose of this study is to evaluate the clinical outcomes of post-myopic refractive surgery patients implanted with the Clareon Vivity/Vivity Toric lenses
Interventions
PROCEDUREcataract surgery
cataract surgery treated with bilateral Clareon Vivity toric and non-toric IOL
Sponsors
Utah Eye Centers
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* o Bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing uncomplicated bilateral sequential Clareon Vivity IOLs * Prior history of uncomplicated post-refractive myopic surgery (LASIK/PRK) with up to 1 enhancement treatment * Potential acuity measured post-operatively 20/25 or better in both eyes * Patients with regular astigmatism that can be managed with T3 toric lens or arcuate incision
Exclusion criteria
* o Ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, etc. * Prior ocular surgeries other than uncomplicated corneal refractive surgery and excluding RK * Patients with irregular astigmatism/topography (to rule out signs of potential ectasia), corneal dystrophies, and pupil abnormalities * Total HOA cutoff of ≤0.5, coma ≤0.3 * RLE patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular photopic uncorrected distance VA (at 3 months) | at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| • Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm) | at 3 months |
Other
| Measure | Time frame |
|---|---|
| Monocular and binocular best distance corrected distance, intermediate, and near VA | at 3 months |
| Monocular uncorrected distance, intermediate, and near VA | at 3 months |
| Mean difference of MRSE between dominant and non-dominant eye | at 3 months |
| Binocular photopic low contrast distance corrected VA | at 3 months |
| Visual disturbances via QUVID questionnaire | at 3 months |
| Potential association between HOA (SA and coma) and monocular DCVAs | at 3 months |
| % of eyes with absolute prediction error less than or equal to 0.5D | at 3 months |
| Mean refractive spherical equivalent (MRSE) for dominant and non-dominant eye | at 3 months |
Countries
United States
Contacts
Primary ContactRachel Buchanan
Outcome results
None listed