Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aphakia
- Sponsor
- Alcon Research
- Locations
- 1
- Primary Endpoint
- Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand and sign an approved informed consent;
- •Willing and able to attend all scheduled study visits as required per protocol;
- •Diagnosed with cataracts in both eyes;
- •Pre-operative regular corneal astigmatism less than 1.0 diopter (D);
- •Planned bilateral cataract removal by phacoemulsification.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
- •Clinically significant corneal diseases;
- •Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
- •Previous intraocular surgery history;
- •Pregnancy or lactation during study or planning to be pregnant/lactating;
- •Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
- •Other planned ocular surgical procedures;
- •Patients who can only undergo cataract surgery in one eye.
- •Other protocol-specified exclusion criteria may apply.
Outcomes
Primary Outcomes
Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye
Time Frame: 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 severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)
Time Frame: Up to Month 12 post second eye implantation
Subjects will be surveyed using the QUVID questionnaire.
Incidence of ocular adverse events
Time Frame: Up to Month 12 post second eye implantation
Ocular adverse events will be reported.
Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye
Time Frame: 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.
Incidence of secondary surgical interventions (SSIs)
Time Frame: Up to Month 12 post second eye implantation
Secondary surgical interventions will be reported.
Secondary Outcomes
- Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye(Month 6 post second eye implantation)