Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Extended depth of focus, Multifocal intraocular lens, Presbyopia, Cataract surgery
Eligibility Criteria
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
Sites / Locations
- Department of Ophthalmology, Yonsei Univeristy College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Symfony group
Arm Description
The subjects who underwent cataract surgery with binocular implantation of either Symfony or Symfony toric IOLs
Outcomes
Primary Outcome Measures
Visual outcome
1. Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Visual outcome
2. Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Visual outcome
3. Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.
Visual outcome
4. Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.
Visual outcome
1. Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Visual outcome
2. Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Visual outcome
3. Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.
Visual outcome
4. Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.
Secondary Outcome Measures
Spectacle use
Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities.
Spectacle use
Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities.
Photic phenomena
Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe.
Photic phenomena
Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe.
Patient Satisfaction
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.
Patient Satisfaction
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03997890
Brief Title
Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL
Official Title
Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 13, 2016 (Actual)
Primary Completion Date
January 18, 2018 (Actual)
Study Completion Date
January 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Extended depth of focus, Multifocal intraocular lens, Presbyopia, Cataract surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Symfony group
Arm Type
Experimental
Arm Description
The subjects who underwent cataract surgery with binocular implantation of either Symfony or Symfony toric IOLs
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs
Intervention Description
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 Outcome Measure Information:
Title
Visual outcome
Description
1. Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Time Frame
preoperative 4-6 weeks
Title
Visual outcome
Description
2. Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Time Frame
preoperative 4-6 weeks
Title
Visual outcome
Description
3. Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.
Time Frame
preoperative 4-6 weeks
Title
Visual outcome
Description
4. Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.
Time Frame
preoperative 4-6 weeks
Title
Visual outcome
Description
1. Uncorrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Time Frame
preoperative 4-6 months
Title
Visual outcome
Description
2. Corrected Distance Vision Acuity (4 meters) in logMAR scale at each time point.
Time Frame
preoperative 4-6 months
Title
Visual outcome
Description
3. Uncorrected Intermediate Visual Acuity (70 cm) in logMAR scale at each time point.
Time Frame
preoperative 4-6 months
Title
Visual outcome
Description
4. Uncorrected Near Visual Acuity (40 cm) in logMAR scale at each time point.
Time Frame
preoperative 4-6 months
Secondary Outcome Measure Information:
Title
Spectacle use
Description
Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities.
Time Frame
Postoperative 4-6 weeks
Title
Spectacle use
Description
Patients were asked how often (never, occasionally, 50% of the time, frequently) participants wear spectacles for near, intermediate, and distance activities.
Time Frame
Postoperative 4-6 months
Title
Photic phenomena
Description
Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe.
Time Frame
Postoperative 4-6 weeks
Title
Photic phenomena
Description
Photic phenomena (halos, glare and starbursts) were graded as none, trace, mild, moderate, or severe.
Time Frame
Postoperative 4-6 months
Title
Patient Satisfaction
Description
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.
Time Frame
Postoperative 4-6 weeks
Title
Patient Satisfaction
Description
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.
Time Frame
Postoperative 4-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Ophthalmology, Yonsei Univeristy College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL
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