Symfony vs Vivity in Dim Light

NCT06229106 | Completed Phase 4 Results FDA Device

• 1 other identifier: CEP 23-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

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

  logMAR visual acuity

  3 months after surgery

Secondary Outcomes (2)

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

  3 months after surgery

• Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions

  3 months after surgery

Study Arms (2)

Symfony IOL

ACTIVE COMPARATOR

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.

Device: Symfony IOL

Vivity IOL

ACTIVE COMPARATOR

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.

Device: Vivity IOL

Interventions

Symfony IOL DEVICE

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.

Symfony IOL

Vivity IOL DEVICE

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.

Vivity IOL

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU.
• Gender: Males and Females.
• Age: 50 years and older.
• Willing and able to provide written informed consent for participation in the study
• Willing and able to comply with scheduled visits and other study procedures.
• Scheduled to undergo standard cataract surgery in both eyes, with 1 to 30 days between surgeries.
• Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

You may not qualify if:

• Severe preoperative ocular pathology
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis.
• Clinically significant corneal dystrophy.
• Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities.
• History of chronic intraocular inflammation.
• History of retinal detachment.
• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
• Previous intraocular surgery.
• Previous corneal refractive surgery (i.e., LASIK, PRK, RK).
• Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos)
• Previous keratoplasty
• Severe dry eye

Sponsors & Collaborators

• Carolina Eyecare Physicians, LLC: lead
• Science in Vision: collaborator

Study Sites (2)

Center for Sight

Sarasota, Florida, 34239, United States

Location

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Carolina Eyecare Physicians, LLC

hsandoval@cepmd.com

8438813937

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: December 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)