Status:
COMPLETED
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
Lead Sponsor:
Alcon Research
Conditions:
Aphakia
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral...
Detailed Description
A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within ...
Eligibility Criteria
Inclusion
- Planned cataract removal in both eyes.
- Willing and able to complete all required postoperative visits.
- Able to understand, read and write English and willing to sign an approved statement of informed consent.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
- Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
- Ocular trauma or ocular surface disease that would affect study measurements.
- Patients who desire monovision correction.
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2021
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT04098367
Start Date
November 18 2019
End Date
July 22 2021
Last Update
May 4 2022
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Alcon Investigator 8047
Charlestown, New South Wales, Australia, 2290
2
Alcon Investigator 6667
Sydney, New South Wales, Australia, 2067
3
Alcon Investigator 7678
Sydney, New South Wales, Australia, 2150
4
Alcon Investigator 8052
Eastwood, South Australia, Australia, 5063