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

NCT03997890 | Completed DMC

• 1 other identifier: 1-2016-0029
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract

Keywords

Extended depth of focus; Multifocal intraocular lens; Presbyopia; Cataract surgery

Outcome Measures

Primary Outcomes (8)

• Visual outcome

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

  preoperative 4-6 weeks

• Visual outcome

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

  preoperative 4-6 weeks

• Visual outcome

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

  preoperative 4-6 weeks

• Visual outcome

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

  preoperative 4-6 weeks

• Visual outcome

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

  preoperative 4-6 months

• Visual outcome

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

  preoperative 4-6 months

• Visual outcome

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

  preoperative 4-6 months

• Visual outcome

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

  preoperative 4-6 months

Secondary Outcomes (6)

• Spectacle use

  Postoperative 4-6 weeks

• Spectacle use

  Postoperative 4-6 months

• Photic phenomena

  Postoperative 4-6 weeks

• Photic phenomena

  Postoperative 4-6 months

• Patient Satisfaction

  Postoperative 4-6 weeks

Study Arms (1)

Symfony group

EXPERIMENTAL

The subjects who underwent cataract surgery with binocular implantation of either Symfony or Symfony toric IOLs

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

Interventions

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.

Symfony group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age of 20 years or older
• \. Cataract

You may not qualify if:

• \. Amblyopia
• \. Keratoconus
• \. Previous corneal or refractive surgery
• \. Chronic or recurrent uveitis
• \. Acute ocular disease
• \. Previous ocular surgeries
• \. Glaucoma
• \. Any ocular disease which could possible affect the postoperative visual acuity

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

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

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 25, 2019
• Study Start: July 13, 2016
• Primary Completion: January 18, 2018
• Study Completion: January 18, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)