Symfony vs Vivity in Dim Light

Carolina Eyecare Physicians, LLC64 enrolled

Overview

The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Cataract

Interventions

Symfony IOLDEVICE

The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.

Vivity IOLDEVICE

The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU. 2. Gender: Males and Females. 3. Age: 50 years and older. 4. Willing and able to provide written informed consent for participation in the study 5. Willing and able to comply with scheduled visits and other study procedures. 6. Scheduled to undergo standard cataract surgery in both eyes, with 1 to 30 days between surgeries. 7. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes. Exclusion Criteria: 1. Severe preoperative ocular pathology 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. Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities. 8. History of chronic intraocular inflammation. 9. History of retinal detachment. 10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. 11. Previous intraocular surgery. 12. Previous corneal refractive surgery (i.e., LASIK, PRK, RK). 13. Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos) 14. Previous keratoplasty 15. Severe dry eye 16. Pupil abnormalities 17. Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK) 18. 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. 19. 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.

Locations (2)

Center for Sight

Sarasota, Florida, United States

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, United States

Outcomes

Primary Outcomes

Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.

logMAR visual acuity

Time frame: 3 months after surgery

Secondary Outcomes

Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.

Time frame: 3 months after surgery

Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions

Visual acuity measured at 4 m

Time frame: 3 months after surgery

Data from ClinicalTrials.gov

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