Trial Outcomes & Findings for Symfony vs Vivity in Dim Light (NCT NCT06229106)
NCT ID: NCT06229106
Last Updated: 2025-02-14
Results Overview
logMAR visual acuity
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
3 months after surgery
Results posted on
2025-02-14
Participant Flow
Participant milestones
| Measure |
Symfony Optiblue IOL
The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
Clareon Vivity IOL
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Symfony vs Vivity in Dim Light
Baseline characteristics by cohort
| Measure |
Symfony Optiblue IOL
n=32 Participants
The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
Clareon Vivity IOL
n=32 Participants
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.18 years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
70.16 years
STANDARD_DEVIATION 5.62 • n=7 Participants
|
70.17 years
STANDARD_DEVIATION 6.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after surgerylogMAR visual acuity
Outcome measures
| Measure |
Symfony Optiblue IOL
n=31 Participants
The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
Clareon Vivity IOL
n=31 Participants
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
|---|---|---|
|
Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.
|
0.27 logMAR
Standard Deviation 0.17
|
0.32 logMAR
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 3 months after surgeryOutcome measures
| Measure |
Symfony Optiblue IOL
n=31 Participants
The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
Clareon Vivity IOL
n=31 Participants
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
|---|---|---|
|
Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.
|
0.54 logMAR
Standard Deviation 0.15
|
0.52 logMAR
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 3 months after surgeryVisual acuity measured at 4 m
Outcome measures
| Measure |
Symfony Optiblue IOL
n=31 Participants
The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
Clareon Vivity IOL
n=31 Participants
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
|
|---|---|---|
|
Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions
|
0.44 logMAR
Standard Deviation 0.1
|
0.43 logMAR
Standard Deviation 0.1
|
Adverse Events
Symfony Optiblue IOL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clareon Vivity IOL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Research
Carolina Eyecare Physicians, LLC
Phone: 8438813937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place