Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extended depth of focus; Multifocal intraocular lens; Presbyopia; Cataract surgery