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OpenTrials
Completed

NCT Number: NCT03082599

Symfony Toric Intraocular Lens Visual Outcomes

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.

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Key information

Conditions

Cataract Bilateral Astigmatism Bilateral Cataract Eye Diseases Lens Diseases

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Associated Eye Care, Stillwater, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Binocular Distance-corrected Near (40 cm) Visual Acuity.

    Time frame: 3 months

    Visual acuity with correction (glasses) measured at 40 cm.

  2. Reduction of Manifest Cylinder (Diopters).

    Time frame: 3 months

Secondary outcomes

  1. Uncorrected Near (40 cm) Visual Acuity

    Time frame: 3 months

    Visual acuity without correction (no glasses) measured at 40 cm.

  2. Uncorrected Intermediate (66 cm) Visual Acuity

    Time frame: 3 months

    Visual acuity without correction (no glasses) measured at 66 cm.

  3. Uncorrected (4 m) Visual Acuity

    Time frame: 3 months

    Visual acuity without correction (no glasses) measured at 4 m.

  4. Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)

    Time frame: 3 months

    Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire.

  5. Patient Reported Spectacle Independence Questionnaire

    Time frame: 3 months

    Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.

Other outcomes

  1. Residual Mean Spherical Equivalent Refraction

    Time frame: 3 months

  2. Residual Refractive Sphere

    Time frame: 3 months

  3. Residual Refractive Cylinder

    Time frame: 3 months

  4. Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Carolina Eyecare Physicians, LLC

Other

Collaborators

  • Abbott Medical Optics
  • Science in Vision

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 17, 2017
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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