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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cataract surgery | Procedure | cataract surgery treated with bilateral Clareon Vivity toric and non-toric IOL |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic uncorrected distance VA (at 3 months) | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| • Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm) | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular uncorrected distance, intermediate, and near VA | at 3 months | |
| Monocular and binocular best distance corrected distance, intermediate, and near VA | at 3 months | |
Inclusion Criteria:
o Bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing uncomplicated bilateral sequential Clareon Vivity IOLs
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.
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Adult subjects with bilateral age-related cataract patients with history of myopic refractive surgery (LASIK/PRK)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Buchanan | Contact | 8014099873 | rbuchanan@utaheyecenters.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Utah Eye Centers | Recruiting | Ogden | Utah | 84403 | United States |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Binocular photopic low contrast distance corrected VA |
| at 3 months |
| Mean refractive spherical equivalent (MRSE) for dominant and non-dominant eye | at 3 months |
| Mean difference of MRSE between dominant and non-dominant eye | at 3 months |
| % of eyes with absolute prediction error less than or equal to 0.5D | at 3 months |
| Visual disturbances via QUVID questionnaire | at 3 months |
| Potential association between HOA (SA and coma) and monocular DCVAs | at 3 months |