Symfony Toric Intraocular Lens Visual Outcomes

Status:	Completed
Conditions:	Ocular, Ocular
Therapuetic Areas:	Ophthalmology
Healthy:	No
Age Range:	40 - 99
Updated:	6/22/2018
Start Date:	February 17, 2017
End Date:	April 3, 2018

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

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.

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.

We found this trial at

sites

Slade & Baker Vision Center

Houston, Texas 77027

Principal Investigator: Stephen Slade, MD

Phone: 713-626-5544

from

Houston, TX