Symfony Toric Intraocular Lens Visual Outcomes
Study Details
Study Description
Brief Summary
In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Emmetropia both eyes (OU) group Symfony Toric IOL target refraction both eyes emmetropia (±0.25D). |
Device: 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.
|
Experimental: 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Binocular Distance-corrected Near (40 cm) Visual Acuity. [3 months]
Visual acuity with correction (glasses) measured at 40 cm.
- Reduction of Manifest Cylinder (Diopters). [3 months]
Secondary Outcome Measures
- Uncorrected Near (40 cm) Visual Acuity [3 months]
Visual acuity without correction (no glasses) measured at 40 cm.
- Uncorrected Intermediate (66 cm) Visual Acuity [3 months]
Visual acuity without correction (no glasses) measured at 66 cm.
- Uncorrected (4 m) Visual Acuity [3 months]
Visual acuity without correction (no glasses) measured at 4 m.
- Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) [3 months]
Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire.
- Patient Reported Spectacle Independence Questionnaire [3 months]
Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.
Other Outcome Measures
- Residual Mean Spherical Equivalent Refraction [3 months]
- Residual Refractive Sphere [3 months]
- Residual Refractive Cylinder [3 months]
- Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D [3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
-
Willing and able to provide written informed consent for participation in the study
-
Willing and able to comply with scheduled visits and other study procedures.
-
Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
-
Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
-
Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion Criteria:
-
Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
-
Uncontrolled diabetes.
-
Use of any systemic or topical drug known to interfere with visual performance.
-
Contact lens use during the active treatment portion of the trial.
-
Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
-
Clinically significant corneal dystrophy
-
History of chronic intraocular inflammation.
-
History of retinal detachment.
-
Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
-
Previous intraocular surgery.
-
Previous refractive surgery.
-
Previous keratoplasty
-
Severe dry eye
-
Pupil abnormalities
-
Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK)
-
Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
-
Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
-
Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Associated Eye Care | Stillwater | Minnesota | United States | 55082 |
2 | Ophthalmic Consultants of Long Island | Garden City | New York | United States | 11530 |
3 | Carolina Eyecare Physicians, LLC | Mount Pleasant | South Carolina | United States | 29464 |
4 | Slade & Baker Vision Center | Houston | Texas | United States | 77027 |
Sponsors and Collaborators
- Carolina Eyecare Physicians, LLC
- Science in Vision
- Abbott Medical Optics
Investigators
- Study Chair: Kerry D. Solomon, MD, Carolina Eyecare Physicians, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- CEP 2016-002
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Period Title: Overall Study | ||
STARTED | 40 | 39 |
COMPLETED | 39 | 39 |
NOT COMPLETED | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group | Total |
---|---|---|---|
Arm/Group Description | 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. | 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 of all reporting groups |
Overall Participants | 40 | 39 | 79 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
68.3
(7.1)
|
69.0
(9.3)
|
68.7
(8.2)
|
Sex: Female, Male (Count of Participants) | |||
Female |
23
57.5%
|
17
43.6%
|
40
50.6%
|
Male |
17
42.5%
|
22
56.4%
|
39
49.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
40
100%
|
39
100%
|
79
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
3
7.5%
|
3
7.7%
|
6
7.6%
|
White |
37
92.5%
|
36
92.3%
|
73
92.4%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||
United States |
40
100%
|
39
100%
|
79
100%
|
Outcome Measures
Title | Binocular Distance-corrected Near (40 cm) Visual Acuity. |
---|---|
Description | Visual acuity with correction (glasses) measured at 40 cm. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [diopters] |
0.30
(0.14)
|
0.26
(0.13)
|
Title | Reduction of Manifest Cylinder (Diopters). |
---|---|
Description | |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [diopters] |
1.15
(0.77)
|
1.38
(0.80)
|
Title | Uncorrected Near (40 cm) Visual Acuity |
---|---|
Description | Visual acuity without correction (no glasses) measured at 40 cm. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [diopters] |
0.25
(0.12)
|
0.19
(0.12)
|
Title | Uncorrected Intermediate (66 cm) Visual Acuity |
---|---|
Description | Visual acuity without correction (no glasses) measured at 66 cm. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [diopters] |
0.06
(0.10)
|
0.04
(0.08)
|
Title | Uncorrected (4 m) Visual Acuity |
---|---|
Description | Visual acuity without correction (no glasses) measured at 4 m. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [diopters] |
-0.03
(0.08)
|
-0.02
(0.08)
|
Title | Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) |
---|---|
Description | Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Number [percentage of participants] |
100
250%
|
97.4
249.7%
|
Title | Patient Reported Spectacle Independence Questionnaire |
---|---|
Description | Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Number [percentage of participants] |
64.8
162%
|
92.3
236.7%
|
Title | Residual Mean Spherical Equivalent Refraction |
---|---|
Description | |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [diopters] |
-0.20
(0.22)
|
-0.33
(0.33)
|
Title | Residual Refractive Sphere |
---|---|
Description | |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [diopters] |
-0.30
(0.20)
|
-0.48
(0.37)
|
Title | Residual Refractive Cylinder |
---|---|
Description | |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [diopters] |
0.20
(0.25)
|
0.29
(0.27)
|
Title | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D |
---|---|
Description | |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
One subject in the emmetropia group missed the Month 3 visit. |
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 39 |
Measure Eyes | 78 | 78 |
Number [percentage of eyes] |
100
|
88.4
|
Adverse Events
Time Frame | Average 3 months. Adverse events were collected from the moment patient enrolled in the study until exit. | |||
---|---|---|---|---|
Adverse Event Reporting Description | Only eye related events were collected. | |||
Arm/Group Title | Emmetropia Both Eyes (OU) Group | Nanovision Group | ||
Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
Emmetropia Both Eyes (OU) Group | Nanovision Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/40 (0%) | 0/39 (0%) | ||
Serious Adverse Events |
||||
Emmetropia Both Eyes (OU) Group | Nanovision Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/40 (0%) | 0/39 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Emmetropia Both Eyes (OU) Group | Nanovision Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/40 (0%) | 0/39 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Helga P Sandoval, Director of Research |
---|---|
Organization | Carolina Eyecare Physicians, LLC |
Phone | 8438813937 |
helga.sandoval@carolinaeyecare.com |
- CEP 2016-002