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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aphakia
- Sponsor
- Alcon Research
- Enrollment
- 222
- Locations
- 12
- Primary Endpoint
- Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
Time Frame: Month 3 postoperative (Day 120-180 from second eye surgery)
QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Secondary Outcomes
- Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)(Month 3 postoperative (Day 120-180 from second eye surgery))
- Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)(Month 3 postoperative (Day 120-180 from second eye surgery))