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Symfony Toric Intraocular Lens Visual Outcomes

Primary Purpose

Cataract Bilateral, Astigmatism Bilateral

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Presbyopia and astigmatism correcting intraocular lens
Sponsored by
Carolina Eyecare Physicians, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Bilateral

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Associated Eye Care
  • Ophthalmic Consultants of Long Island
  • Carolina Eyecare Physicians, LLC
  • Slade & Baker Vision Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Emmetropia both eyes (OU) group

Nanovision group

Arm Description

Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).

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.

Outcomes

Primary Outcome Measures

Binocular Distance-corrected Near (40 cm) Visual Acuity.
Visual acuity with correction (glasses) measured at 40 cm.
Reduction of Manifest Cylinder (Diopters).

Secondary Outcome Measures

Uncorrected Near (40 cm) Visual Acuity
Visual acuity without correction (no glasses) measured at 40 cm.
Uncorrected Intermediate (66 cm) Visual Acuity
Visual acuity without correction (no glasses) measured at 66 cm.
Uncorrected (4 m) Visual Acuity
Visual acuity without correction (no glasses) measured at 4 m.
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.
Patient Reported Spectacle Independence Questionnaire
Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.

Full Information

First Posted
March 6, 2017
Last Updated
January 23, 2020
Sponsor
Carolina Eyecare Physicians, LLC
Collaborators
Science in Vision, Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT03082599
Brief Title
Symfony Toric Intraocular Lens Visual Outcomes
Official Title
Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
April 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carolina Eyecare Physicians, LLC
Collaborators
Science in Vision, Abbott Medical Optics

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Bilateral, Astigmatism Bilateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emmetropia both eyes (OU) group
Arm Type
Active Comparator
Arm Description
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
Arm Title
Nanovision group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Presbyopia and astigmatism correcting intraocular lens
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binocular Distance-corrected Near (40 cm) Visual Acuity.
Description
Visual acuity with correction (glasses) measured at 40 cm.
Time Frame
3 months
Title
Reduction of Manifest Cylinder (Diopters).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Uncorrected Near (40 cm) Visual Acuity
Description
Visual acuity without correction (no glasses) measured at 40 cm.
Time Frame
3 months
Title
Uncorrected Intermediate (66 cm) Visual Acuity
Description
Visual acuity without correction (no glasses) measured at 66 cm.
Time Frame
3 months
Title
Uncorrected (4 m) Visual Acuity
Description
Visual acuity without correction (no glasses) measured at 4 m.
Time Frame
3 months
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
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
Other Pre-specified Outcome Measures:
Title
Residual Mean Spherical Equivalent Refraction
Time Frame
3 months
Title
Residual Refractive Sphere
Time Frame
3 months
Title
Residual Refractive Cylinder
Time Frame
3 months
Title
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry D. Solomon, MD
Organizational Affiliation
Carolina Eyecare Physicians, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Associated Eye Care
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Carolina Eyecare Physicians, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Slade & Baker Vision Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Symfony Toric Intraocular Lens Visual Outcomes

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