Aphakia, Presbyopia, Residual Refractive Cylinder
Conditions
Keywords
Cataracts
Brief summary
The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.
Detailed description
This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world. This study will be conducted in the US and in Spain.
Interventions
UV-absorbing, with or without blue light filtering, foldable IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients from whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing an extended depth of focus. The toric models in addition reduce residual refractive astigmatism in patients with pre-existing corneal astigmatism.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 22 years old or older at Visit 1. * Able to understand and sign an approved informed consent form. * Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment. * Documented medical history and required pre-operative baseline information available for retrospective data collection. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation. * Pregnant or nursing at the time of enrollment. * Childbirth after IOL implantation. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1 | Visit 1, Year 3-5 postoperative | Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place using letter charts at a distance of 4 meters. BCVA will be recorded in logarithm Minimum Angle of Resolution (logMAR) LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. No hypothesis testing is prespecified for this endpoint. |
| Incidence of adverse events | Up to Year 3-5 postoperative | An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study device. Adverse events reported or observed since the time of initial exposure to the study model IOL will be recorded. |
| Incidence of device deficiencies | Up to Year 3-5 postoperative | A device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. Device deficiencies reported or observed since the time of initial exposure to the study model IOL will be recorded. |
Countries
United States
Outcome results
None listed