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OpenTrials
Completed

NCT Number: NCT03997890

Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL

In With increased patients' demand for a spectacle-free lifestyle and technological advancements, cataract surgery with multifocal intraocular lens (IOL) implantation has become an effective solution for correcting presbyopia in patients who want to maintain their full range of vision.

Conventional bifocal IOLs used either refractive or diffractive optics to split the light and create 2 principal focal points, thus providing functional vision at distance and near. This simultaneous imaging principle produces a sharp image that is overlaid by a secondary blurred out-of focus image, so these IOLs inherently produce a deterioration in contrast sensitivity and unwanted photic phenomena such as glare and halos. Additionally, studies reported insufficient intermediate vision with bifocal IOLs.

There is an increasing desire for spectacle independence at intermediate distance, especially due to the increased use of computers and smartphones. Trifocal IOLs were introduced to the market in 2010 and participants provide an additional, third focal point to improve intermediate vision without compromising distance and near vision. However, participants are still vulnerable to decreased contrast sensitivity and photic phenomena due to the IOL's mechanism of splitting the light into discrete focal points.

An extended depth of focus (EDOF) technology was recently introduced with the aim to improve intermediate vision while maintaining image contrast. The diffractive echelette design, embedded on its posterior optical surface, extends the range of vision and the achromatic technology reduces corneal chromatic aberrations to enhance retinal image quality and improve contrast sensitivity. The elongated focus allows imaging in a continuous range of vision without overlapping near and far images, and therefore theoretically would provide a more consistent distance and intermediate vision with less dysphotopsia.

The aim of this study was to investigate the clinical outcome of patients bilaterally implanted with either Tecnis Symfony or Tecnis Symfony toric extended range of vision IOLs (Johnson & Johnson Vision, Santa Ana, CA, USA) in terms of visual performance at different distances, spectacle independence, photic phenomena, and patient satisfaction.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, 03722, South Korea

About this study

Enrollment period : 18 months after IRB approval Participants : Patients who had uncomplicated cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs.

Methods: The postoperative examinations were performed at 4-8 weeks, and 4-6 months postoperatively. Binocular corrected (CDVA) and uncorrected (UDVA) distance visual acuity was assessed at 4 m using a Snellen chart. Binocular uncorrected intermediate visual acuity (UIVA) at 70 cm and binocular uncorrected near visual acuity (UNVA) at 40 cm were assessed using the Rosenbaum near vision card.

A subjective questionnaire on spectacle use, photic phenomena, and satisfaction was administered to all patients. Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities. Non-directed and directed questions were used with regard to visual symptoms. Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe. Patients were asked to rate their level of satisfaction with distance, intermediate, and near vision on a scale from 0 (completely dissatisfied) to 10 (completely satisfied). Additionally, participants were asked whether participants would choose the same IOL again and if participants would recommend the IOL to their friends and family. Surgeons were also asked to rate their level of satisfaction on a scale from 0 to 10 in terms of the ease of manipulation and implantation of the IOL and the visual performance of the IOL.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Age of 20 years or older
  • 2. Cataract

Exclusion criteria

  • 1. Amblyopia
  • 2. Keratoconus
  • 3. Previous corneal or refractive surgery
  • 4. Chronic or recurrent uveitis
  • 5. Acute ocular disease
  • 6. Previous ocular surgeries
  • 7. Glaucoma
  • 8. Any ocular disease which could possible affect the postoperative visual acuity

Treatment and study plan

Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs

Procedure

After creating an initial side port incision with a 15-degree blade, 3-step clear corneal incisions were made using a 2.5 mm disposable metal blade. Sodium hyaluronate 1.0% (Healon; Abbott Medical Optics) was then injected into the anterior chamber. A continuous curvilinear capsulorrhexis, measuring 5.5 mm in diameter, was generated using a 26 gauge bent needle. After hydrodissection, phacoemulsification was done to remove nuclear fragments and aspiration of residual cortex. In all eyes, a Symfony or Symfony toric IOL was implanted in the capsular bag using a disposable implantation system. Irrigation and aspiration were performed to minimize ophthalmic viscoelastic surgical device retention at the end of surgery. The main incision and side port were sealed with stromal hydration using a balanced salt solution.

Primary outcomes

  1. Visual outcome

    Time frame: preoperative 4-6 weeks

    • Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.

  2. Visual outcome

    Time frame: preoperative 4-6 weeks

    • Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.

  3. Visual outcome

    Time frame: preoperative 4-6 weeks

    • Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.

  4. Visual outcome

    Time frame: preoperative 4-6 weeks

    • Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.

  5. Visual outcome

    Time frame: preoperative 4-6 months

    • Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.

  6. Visual outcome

    Time frame: preoperative 4-6 months

    • Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.

  7. Visual outcome

    Time frame: preoperative 4-6 months

    • Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.

  8. Visual outcome

    Time frame: preoperative 4-6 months

    • Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.

Secondary outcomes

  1. Spectacle use

    Time frame: Postoperative 4-6 weeks

    Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities.

  2. Spectacle use

    Time frame: Postoperative 4-6 months

    Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities.

  3. Photic phenomena

    Time frame: Postoperative 4-6 weeks

    Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe.

  4. Photic phenomena

    Time frame: Postoperative 4-6 months

    Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe.

  5. Patient Satisfaction

    Time frame: Postoperative 4-6 weeks

    Patients were asked to rate their level of satisfaction with distance, intermediate, and near vision on a scale from 0 (completely dissatisfied) to 10 (completely satisfied). Additionally, participants were asked whether participants would choose the same IOL again and if participants would recommend the IOL to their friends and family.

  6. Patient Satisfaction

    Time frame: Postoperative 4-6 months

    Patients were asked to rate their level of satisfaction with distance, intermediate, and near vision on a scale from 0 (completely dissatisfied) to 10 (completely satisfied). Additionally, participants were asked whether participants would choose the same IOL again and if participants would recommend the IOL to their friends and family.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2019
Registry last updated
Jun 27, 2019

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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