Symfony vs Vivity Lenses for Cataracts

Recruiting at 1 trial location

Overseen By Helga P. Sandoval

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Carolina Eyecare Physicians, LLC

Must not be taking: Vision-interfering drugs

Disqualifiers: Severe ocular pathology, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 50 or older who are having routine cataract surgery in both eyes and expect good vision afterward. They must be able to follow the study's schedule and procedures, have no severe eye conditions, uncontrolled diabetes, history of certain eye surgeries or diseases that could affect their zonules or visual performance.

Inclusion Criteria

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

I am either male or female.

Exclusion Criteria

I have a history of long-term eye inflammation.

I currently have an eye infection or inflammation.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo routine cataract surgery and receive either the Symfony or Vivity intraocular lens

1 day

1 visit (in-person)

Follow-up

Participants are monitored for visual acuity outcomes under mesopic conditions

3 months

Multiple visits (in-person)

Treatment Details

Interventions

• Symfony IOL
• Vivity IOL

Trial Overview The study compares two types of intraocular lenses (IOLs), Symfony and Vivity, used in cataract surgery. It specifically looks at how well patients can see with each lens under dim light by reading a chart at various distances.

Participant Groups

Group I: Symfony IOL Active Control 1 Intervention

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.

Group II: Vivity IOL Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Carolina Eyecare Physicians, LLC

Lead Sponsor

Trials

11

Recruited

600+

Science in Vision

Collaborator

Trials

17

Recruited

800+