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Management decision. No patients enrolled
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The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.
In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 13 months. This study will be conducted in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivity IOL | Experimental | AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof IQ Vivity Extended Vision IOL | Device | UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye | Intermediate visual acuity will be assessed at 66 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. | Month 6 post second eye implantation |
| Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye | Near visual acuity will be assessed at 40 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. . | Month 6 post second eye implantation |
| Incidence of ocular adverse events | Ocular adverse events will be reported. | Up to Month 12 post second eye implantation |
| Incidence of secondary surgical interventions (SSIs) | Secondary surgical interventions will be reported. | Up to Month 12 post second eye implantation |
| Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire) | Subjects will be surveyed using the QUVID questionnaire. | Up to Month 12 post second eye implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye | Distance visual acuity will be assessed at 4 meters (m) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. | Month 6 post second eye implantation |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Surgical | Alcon (China) Ophthalmic Product Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan Bo'ao Super Hospital Co., Ltd. | Qionghai | Hainan | China |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D011305 | Presbyopia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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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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| Cataract surgery | Procedure | Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL |
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