Trial Outcomes & Findings for Symfony Toric Intraocular Lens Visual Outcomes (NCT NCT03082599)
NCT ID: NCT03082599
Last Updated: 2020-01-27
Results Overview
Visual acuity with correction (glasses) measured at 40 cm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
3 months
Results posted on
2020-01-27
Participant Flow
A total of 120 patients were enrolled and randomized; however, data from only 79 patients was analyzed due to major procedural issues at one site. One patient in the Emmetropia group missed the 3-month visit.
Participant milestones
| Measure |
Emmetropia Both Eyes (OU) Group
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Emmetropia Both Eyes (OU) Group
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Symfony Toric Intraocular Lens Visual Outcomes
Baseline characteristics by cohort
| Measure |
Emmetropia Both Eyes (OU) Group
n=40 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Visual acuity with correction (glasses) measured at 40 cm.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Binocular Distance-corrected Near (40 cm) Visual Acuity.
|
0.30 diopters
Standard Deviation 0.14
|
0.26 diopters
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Reduction of Manifest Cylinder (Diopters).
|
1.15 diopters
Standard Deviation 0.77
|
1.38 diopters
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Visual acuity without correction (no glasses) measured at 40 cm.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Uncorrected Near (40 cm) Visual Acuity
|
0.25 diopters
Standard Deviation 0.12
|
0.19 diopters
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Visual acuity without correction (no glasses) measured at 66 cm.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Uncorrected Intermediate (66 cm) Visual Acuity
|
0.06 diopters
Standard Deviation 0.10
|
0.04 diopters
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Visual acuity without correction (no glasses) measured at 4 m.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Uncorrected (4 m) Visual Acuity
|
-0.03 diopters
Standard Deviation 0.08
|
-0.02 diopters
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)
|
100 percentage of participants
|
97.4 percentage of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Patient Reported Spectacle Independence Questionnaire
|
64.8 percentage of participants
|
92.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Residual Mean Spherical Equivalent Refraction
|
-0.20 diopters
Standard Deviation 0.22
|
-0.33 diopters
Standard Deviation 0.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Residual Refractive Sphere
|
-0.30 diopters
Standard Deviation 0.20
|
-0.48 diopters
Standard Deviation 0.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=39 Participants
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=39 Participants
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Residual Refractive Cylinder
|
0.20 diopters
Standard Deviation 0.25
|
0.29 diopters
Standard Deviation 0.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: One subject in the emmetropia group missed the Month 3 visit.
Outcome measures
| Measure |
Emmetropia Both Eyes (OU) Group
n=78 Eyes
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
Nanovision Group
n=78 Eyes
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|---|---|---|
|
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D
|
100 percentage of eyes
|
88.4 percentage of eyes
|
Adverse Events
Emmetropia Both Eyes (OU) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nanovision Group
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
Dr. Helga P Sandoval, Director of Research
Carolina Eyecare Physicians, LLC
Phone: 8438813937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place