Clinical trial NCT03082599: Symfony Toric Intraocular Lens Visual Outcomes
Official title: Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Bilateral
Astigmatism Bilateral
Lead sponsor: Carolina Eyecare Physicians, LLC
Sponsor class: OTHER
Collaborators: name: Science in Vision
name: Abbott Medical Optics
First posted: 2017-03-17
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Binocular Distance-corrected Near (40 cm) Visual Acuity.
timeFrame: 3 months
measure: Reduction of Manifest Cylinder (Diopters).
timeFrame: 3 months
Secondary outcomes:
measure: Uncorrected Near (40 cm) Visual Acuity
timeFrame: 3 months
measure: Uncorrected Intermediate (66 cm) Visual Acuity
timeFrame: 3 months
measure: Uncorrected (4 m) Visual Acuity
timeFrame: 3 months
measure: Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)
timeFrame: 3 months
measure: Patient Reported Spectacle Independence Questionnaire
timeFrame: 3 months
Other outcomes:
measure: Residual Mean Spherical Equivalent Refraction
timeFrame: 3 months
measure: Residual Refractive Sphere
timeFrame: 3 months
measure: Residual Refractive Cylinder
timeFrame: 3 months
measure: Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D
timeFrame: 3 months
Locations:
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Garden City
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
city: Houston
country: United States
facility: Slade & Baker Vision Center
state: Texas
Study officials:
affiliation: Carolina Eyecare Physicians, LLC
name: Kerry D. Solomon, MD
role: STUDY_CHAIR
References: