Symfony Toric Intraocular Lens Visual Outcomes

Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03082599

Enrollment

120

Registered

2017-03-17

Start date

2017-02-17

Completion date

2018-04-03

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism Bilateral, Cataract Bilateral

Brief summary

In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.

Interventions

DEVICEPresbyopia and astigmatism correcting intraocular lens

The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 99 Years

Healthy volunteers

Inclusion criteria

1. Subject is undergoing bilateral cataract extraction with intraocular lens implantation. 2. Willing and able to provide written informed consent for participation in the study 3. Willing and able to comply with scheduled visits and other study procedures. 4. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries. 5. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only. 6. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion criteria

1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc. 2. Uncontrolled diabetes. 3. Use of any systemic or topical drug known to interfere with visual performance. 4. Contact lens use during the active treatment portion of the trial. 5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. 6. Clinically significant corneal dystrophy 7. History of chronic intraocular inflammation. 8. History of retinal detachment. 9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. 10. Previous intraocular surgery. 11. Previous refractive surgery. 12. Previous keratoplasty 13. Severe dry eye 14. Pupil abnormalities 15. Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK) 16. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). 17. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. 18. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Design outcomes

Primary

Measure	Time frame	Description
Binocular Distance-corrected Near (40 cm) Visual Acuity.	3 months	Visual acuity with correction (glasses) measured at 40 cm.
Reduction of Manifest Cylinder (Diopters).	3 months	—

Secondary

Measure	Time frame	Description
Uncorrected Intermediate (66 cm) Visual Acuity	3 months	Visual acuity without correction (no glasses) measured at 66 cm.
Uncorrected Near (40 cm) Visual Acuity	3 months	Visual acuity without correction (no glasses) measured at 40 cm.
Uncorrected (4 m) Visual Acuity	3 months	Visual acuity without correction (no glasses) measured at 4 m.
Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)	3 months	Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire.
Patient Reported Spectacle Independence Questionnaire	3 months	Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.

Other

Measure	Time frame
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D	3 months
Residual Refractive Cylinder	3 months
Residual Mean Spherical Equivalent Refraction	3 months
Residual Refractive Sphere	3 months

Countries

United States

Participant flow

Pre-assignment details

A total of 120 patients were enrolled and randomized; however, data from only 79 patients was analyzed due to major procedural issues at one site. One patient in the Emmetropia group missed the 3-month visit.

Participants by arm

Arm	Count
Emmetropia Both Eyes (OU) Group Symfony Toric IOL target refraction both eyes emmetropia (±0.25D). Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.	40
Nanovision Group Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D. Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.	39
Total	79

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Emmetropia Both Eyes (OU) Group	Nanovision Group	Total
Age, Continuous	68.3 years STANDARD_DEVIATION 7.1	69.0 years STANDARD_DEVIATION 9.3	68.7 years STANDARD_DEVIATION 8.2
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants	39 Participants	79 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	3 Participants	6 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	37 Participants	36 Participants	73 Participants
Region of Enrollment United States	40 Participants	39 Participants	79 Participants
Sex: Female, Male Female	23 Participants	17 Participants	40 Participants
Sex: Female, Male Male	17 Participants	22 Participants	39 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 40	0 / 39
other Total, other adverse events	0 / 40	0 / 39
serious Total, serious adverse events	0 / 40	0 / 39

Outcome results

Primary