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This is study to determine the visual performance of patients with age-related cataracts implanted in both eyes with either of two extended depth of focus intraocular lenses, the Clareon Vivity (Alcon Healthcare) or the PureSee (Johnson & Johnson)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended depth of focus intraocular lens Clareon Vivity | Experimental |
| |
| Extended depth of focus intraocular lens PureSee | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phacoemulsification with implantation of an extended depth of focus intraocular lens | Device | Comparison of two different Extended depth of focus intraocular lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance-corrected binocular defocus curve at 4 m | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular and binocular, corrected and uncorrected distance, intermediate, and near visual acuities | Visual acuities in logMAR scale using ETDRS (Early Treatment Diabetic Retinopathy Study) charts | 3 months |
| Distance-corrected contrast sensitivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OMIQ Research | Recruiting | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Contrast sensitivity using M&S device
| Three months |
| Low contrast (25%) binocular distance-corrected visual acuity | Contrast sensitivity in logMAR scale using low contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts | 3 months |
| Visual dysfunction assessment using the QUVID (Questionnaire for visual disturbances) questionnaire | Assessment of qualitative visual dysphotopsia using a specific validated questionnaire | 3 months |
| Spectacle independence assessment using the IOLSAT (Intraocular lens satisfaction) questionnaire | Assessment of recent use of spectacles to see at different distances using a specific questionnaire | 3 months |
| D059708 | Ultrasonic Surgical Procedures |