Clinical trial NCT03997890: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Extended depth of focus
Multifocal intraocular lens
Presbyopia
Cataract surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual outcome
timeFrame: preoperative 4-6 weeks
measure: Visual outcome
timeFrame: preoperative 4-6 weeks
measure: Visual outcome
timeFrame: preoperative 4-6 weeks
measure: Visual outcome
timeFrame: preoperative 4-6 weeks
measure: Visual outcome
timeFrame: preoperative 4-6 months
measure: Visual outcome
timeFrame: preoperative 4-6 months
measure: Visual outcome
timeFrame: preoperative 4-6 months
measure: Visual outcome
timeFrame: preoperative 4-6 months
Secondary outcomes:
measure: Spectacle use
timeFrame: Postoperative 4-6 weeks
measure: Spectacle use
timeFrame: Postoperative 4-6 months
measure: Photic phenomena
timeFrame: Postoperative 4-6 weeks
measure: Photic phenomena
timeFrame: Postoperative 4-6 months
measure: Patient Satisfaction
timeFrame: Postoperative 4-6 weeks
measure: Patient Satisfaction
timeFrame: Postoperative 4-6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Yonsei Univeristy College of Medicine
Study officials:
References: