Symfony Toric Intraocular Lens Visual Outcomes

Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)

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.

Study Overview

• Status: Completed
• Conditions: Cataract Bilateral; Astigmatism Bilateral
• Intervention / Treatment: Device: Presbyopia and astigmatism correcting intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Stillwater, Minnesota, United States, 55082
      • Associated Eye Care
  • New York
    • Garden City, New York, United States, 11530
      • Ophthalmic Consultants of Long Island
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina EyeCare Physicians, LLC
  • Texas
    • Houston, Texas, United States, 77027
      • Slade & Baker Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
2. Willing and able to provide written informed consent for participation in the study
3. Willing and able to comply with scheduled visits and other study procedures.
4. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
5. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
6. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. 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.
2. Uncontrolled diabetes.
3. Use of any systemic or topical drug known to interfere with visual performance.
4. Contact lens use during the active treatment portion of the trial.
5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
6. Clinically significant corneal dystrophy
7. History of chronic intraocular inflammation.
8. History of retinal detachment.
9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
10. Previous intraocular surgery.
11. Previous refractive surgery.
12. Previous keratoplasty
13. Severe dry eye
14. Pupil abnormalities
15. 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)
16. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
17. 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.
18. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Distance-corrected Near (40 cm) Visual Acuity.	Visual acuity with correction (glasses) measured at 40 cm.	3 months
Reduction of Manifest Cylinder (Diopters).		3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Near (40 cm) Visual Acuity	Visual acuity without correction (no glasses) measured at 40 cm.	3 months
Uncorrected Intermediate (66 cm) Visual Acuity	Visual acuity without correction (no glasses) measured at 66 cm.	3 months
Uncorrected (4 m) Visual Acuity	Visual acuity without correction (no glasses) measured at 4 m.	3 months
Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)	Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire.	3 months
Patient Reported Spectacle Independence Questionnaire	Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.	3 months

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Carolina Eyecare Physicians, LLC
• Collaborators: Abbott Medical Optics; Science in Vision
• Investigators: Study Chair: Kerry D. Solomon, MD, Carolina EyeCare Physicians, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): April 3, 2018
• Study Completion (Actual): April 3, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: CEP 2016-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes