Symfony Toric Intraocular Lens Visual Outcomes

NCT03082599 | Completed Results FDA Device

• 1 other identifier: CEP 2016-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Cataract Bilateral; Astigmatism Bilateral

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Uncorrected Near (40 cm) Visual Acuity

  3 months

• Uncorrected Intermediate (66 cm) Visual Acuity

  3 months

• Uncorrected (4 m) Visual Acuity

  3 months

• Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)

  3 months

• Patient Reported Spectacle Independence Questionnaire

  3 months

Other Outcomes (4)

• Residual Mean Spherical Equivalent Refraction

  3 months

• Residual Refractive Sphere

  3 months

• Residual Refractive Cylinder

  3 months

Study Arms (2)

Emmetropia both eyes (OU) group

ACTIVE COMPARATOR

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

Device: Presbyopia and astigmatism correcting intraocular lens

Nanovision group

EXPERIMENTAL

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

Interventions

Presbyopia and astigmatism correcting intraocular lens DEVICE

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.

Emmetropia both eyes (OU) group; Nanovision group

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Carolina Eyecare Physicians, LLC: lead
• Science in Vision: collaborator
• Abbott Medical Optics: collaborator

Study Sites (4)

Associated Eye Care

Stillwater, Minnesota, 55082, United States

Location

Ophthalmic Consultants of Long Island

Garden City, New York, 11530, United States

Location

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Slade & Baker Vision Center

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Helga P Sandoval, Director of Research
• Organization: Carolina Eyecare Physicians, LLC

helga.sandoval@carolinaeyecare.com

8438813937

Study Officials

• Kerry D. Solomon, MD

  Carolina Eyecare Physicians, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 17, 2017
• Study Start: February 17, 2017
• Primary Completion: April 3, 2018
• Study Completion: April 3, 2018
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)