Aphakia, Presbyopia
Conditions
Keywords
Cataract, Intraocular lens
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.
Interventions
UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.
PROCEDURECataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed