Real-World Study of Vivity Intraocular Lenses (IOLs)
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Vivity IOL AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
Device: AcrySof IQ Vivity Extended Vision IOL
UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.
Other Names:
Procedure: Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL
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Outcome Measures
Primary Outcome Measures
- Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye [Month 6 post second eye implantation]
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.
- Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye [Month 6 post second eye implantation]
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. .
- Incidence of ocular adverse events [Up to Month 12 post second eye implantation]
Ocular adverse events will be reported.
- Incidence of secondary surgical interventions (SSIs) [Up to Month 12 post second eye implantation]
Secondary surgical interventions will be reported.
- Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire) [Up to Month 12 post second eye implantation]
Subjects will be surveyed using the QUVID questionnaire.
Secondary Outcome Measures
- Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye [Month 6 post second eye implantation]
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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Able to understand and sign an approved informed consent;
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Willing and able to attend all scheduled study visits as required per protocol;
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Diagnosed with cataracts in both eyes;
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Pre-operative regular corneal astigmatism less than 1.0 diopter (D);
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Planned bilateral cataract removal by phacoemulsification.
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Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
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Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
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Clinically significant corneal diseases;
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Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
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Previous intraocular surgery history;
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Pregnancy or lactation during study or planning to be pregnant/lactating;
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Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
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Other planned ocular surgical procedures;
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Patients who can only undergo cataract surgery in one eye.
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Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hainan Bo'ao Super Hospital Co., Ltd. | Qionghai | Hainan | China |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, Surgical, Alcon (China) Ophthalmic Product Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILI875-P002