A Phase 4 interventional study of Symfony IOL and Vivity IOL in Cataract, sponsored by Carolina Eyecare Physicians, LLC. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Carolina Eyecare Physicians, LLC · Phase 4, Interventional, and Other
The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.
1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 1,171 interventional studies indexed under Cataract.
Browse Cataract studies →Carolina Eyecare Physicians, LLC is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Symfony 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.
Device: Vivity 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.
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.
logMAR visual acuity
Time frame: 3 months after surgery
Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.
Time frame: 3 months after surgery
Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions
Visual acuity measured at 4 m
Time frame: 3 months after surgery
| Milestone | Symfony Optiblue IOL | Clareon Vivity IOL |
|---|---|---|
| Started | 32 | 32 |
| Completed | 31 | 31 |
| Not completed | 1 | 1 |
logMAR visual acuity
| logMAR | Symfony Optiblue IOL | Clareon Vivity IOL |
|---|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions. | 0.27 ± 0.17 | 0.32 ± 0.11 |
| logMAR | Symfony Optiblue IOL | Clareon Vivity IOL |
|---|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions. | 0.54 ± 0.15 | 0.52 ± 0.12 |
Visual acuity measured at 4 m
| logMAR | Symfony Optiblue IOL | Clareon Vivity IOL |
|---|---|---|
| Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions | 0.44 ± 0.1 | 0.43 ± 0.1 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Symfony Optiblue IOL | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Clareon Vivity IOL | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | Symfony Optiblue IOL | Clareon Vivity IOL | Total |
|---|---|---|---|
| Mean | 70.18 ± 7.02 | 70.16 ± 5.62 | 70.17 ± 6.31 |
| Sex: Female, Male(Participants) | Symfony Optiblue IOL | Clareon Vivity IOL | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 17 | 17 | 34 |
| Ethnicity (NIH/OMB)(Participants) | Symfony Optiblue IOL | Clareon Vivity IOL | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 27 | 25 | 52 |
| Unknown or Not Reported | 4 | 7 | 11 |
| Race (NIH/OMB)(Participants) | Symfony Optiblue IOL | Clareon Vivity IOL | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 30 | 30 | 60 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Dec 2023 to primary completion in Oct 2024, 10 months.
Results were first posted in Feb 2025, 3 months after primary completion.
Of 46 non-industry phase 4 interventional studies under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 10 months is below that.
Counting every sponsor, half of 54 studies reached it within 17 months; a quarter within 9 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Carolina Eyecare Physicians, LLC