Symfony Toric Intraocular Lens Visual Outcomes
Symfony Toric Intraocular Lens Visual Outcomes
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.