Presbyopia Clinical Trial
Official title:
Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)
NCT number | NCT04800016 |
Other study ID # | ILI875-P002 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2021 |
Est. completion date | July 2024 |
Verified date | August 2023 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
China | Hainan Bo'ao Super Hospital Co., Ltd. | Qionghai | Hainan |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Incidence of ocular adverse events | Ocular adverse events will be reported. | Up to Month 12 post second eye implantation | |
Primary | Incidence of secondary surgical interventions (SSIs) | Secondary surgical interventions will be reported. | Up to Month 12 post second eye implantation | |
Primary | 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 | |
Secondary | 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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