Clinical trial NCT04098367: Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
Official title: A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Keywords: Cataracts
Extracapsular cataract extraction
IOL
Extended depth of focus
Visual disturbances
Presbyopia
Intraocular lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 222
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.

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 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
timeFrame: Month 3 postoperative (Day 120-180 from second eye surgery)
Secondary outcomes:
measure: Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)
timeFrame: Month 3 postoperative (Day 120-180 from second eye surgery)
measure: Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)
timeFrame: Month 3 postoperative (Day 120-180 from second eye surgery)
Other outcomes:
Locations:
city: Charlestown
country: Australia
facility: Alcon Investigator 8047
state: New South Wales
city: Sydney
country: Australia
facility: Alcon Investigator 6667
state: New South Wales
city: Sydney
country: Australia
facility: Alcon Investigator 7678
state: New South Wales
city: Eastwood
country: Australia
facility: Alcon Investigator 8052
state: South Australia
city: Hobart
country: Australia
facility: Alcon Investigator 7130
state: Tasmania
city: Essendon
country: Australia
facility: Alcon Investigator 8010
state: Victoria
city: Footscray
country: Australia
facility: Alcon Investigator 7813
state: Victoria
city: Mornington
country: Australia
facility: Alcon Investigator 1702
state: Victoria
city: Murdoch
country: Australia
facility: Alcon Investigator 8051
state: Western Australia
city: Auckland
country: New Zealand
facility: Alcon Investigator 8056
city: Auckland
country: New Zealand
facility: Alcon Investigator 8050
city: Wellington
country: New Zealand
facility: Alcon Investigator 3656
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Surgical
role: STUDY_DIRECTOR
References: