Symfony vs Vivity Lenses for Cataracts

No longer recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of lenses used in cataract surgery: Symfony IOL and Vivity IOL. The goal is to determine how well these lenses improve vision under dim lighting conditions after surgery. Those undergoing cataract surgery in both eyes and seeking lenses that might reduce the need for glasses may find this study suitable. Participants will read eye charts in low light as part of the study. As a Phase 4 trial, the lenses have already received FDA approval and proven effective, and this research aims to understand how they benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot use any drugs that interfere with visual performance.

What is the safety track record for these treatments?

Research has shown that both the Symfony and Vivity lenses are safe for cataract surgery.

The Symfony lens improves vision at far, middle, and near distances. It has passed safety tests and received approval for use. Users have experienced enhanced vision without major safety concerns.

The Vivity lens has also proven safe. It enhances vision at various distances and uses special technology to reduce halos and glare. Its approval confirms its safety.

Both lenses have undergone thorough study and offer safe options for improved vision after cataract surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Symfony and Vivity lenses because they offer innovative solutions for cataract patients. Unlike standard monofocal lenses, which typically provide clear vision at only one distance, the Symfony IOL is designed to enhance vision up to 26 inches and reduce the need for glasses, even in those with astigmatism. Meanwhile, the Vivity IOL provides an extended range of vision from distance to near, offering a broader visual spectrum without reliance on glasses. These advancements could significantly improve quality of life for cataract patients by minimizing dependence on corrective eyewear.

What evidence suggests that this trial's lenses could be effective for cataracts?

This trial will compare the Symfony IOL with the Vivity IOL for cataract surgery. Research has shown that the Symfony lens, which participants in this trial may receive, improves vision at various distances, particularly for near and arm's length vision. After cataract surgery, many patients experience enhanced long-distance vision and require glasses less frequently. This lens aids in clear vision both with and without glasses.

Conversely, studies have found that the Vivity lens, another option in this trial, provides good vision for both distant and mid-range distances. Its special technology reduces the need for glasses. Most patients reported satisfaction with their vision and would choose the Vivity lens again. Both lenses aim to provide clear vision at various distances, facilitating everyday tasks without relying on glasses. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

I have had eye surgery before.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10342887/

Assessing Visual Outcomes: A Comparative Study of US- ... PanOptix with a distance CNVA of 0.105 logMAR showed statistically better outcomes than Symfony recorded at 0.323 logMAR (p < 0.0001). There was ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8865208/

Visual outcomes and safety of an extended depth-of-focus ... The TECNIS Symfony IOL provided comparable distance vision and improved uncorrected and distance-corrected intermediate and near vision, along with decreased ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05541796

Clinical Outcomes Following Implantation of Tecnis ... Clinical Outcomes and Patient Satisfaction Following Implantation of Tecnis Synergy and Tecnis Symfony Intraocular Lens. Conditions. Cataract. Cataract.

4. nature.com nature.com/articles/s41598-022-23694-9

Visual outcomes and subjective experience with three ... The outcomes included visual acuity (VA), visual defocus curve, contrast sensitivity, visual quality, quality of life, spectacle independence, and patient ...

5. abbott.mediaroom.com abbott.mediaroom.com/2016-05-08-Abbott-Announces-Positive-Results-from-Pivotal-Study-of-Tecnis-Symfony-IOL-for-Cataract-Surgery

Abbott Announces Positive Results from Pivotal Study of ... "The data from this study showed that patients who received the Symfony lens were more likely to achieve improved intermediate and near vision, ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/p980040s065b.pdf

summary of safety and effectiveness data (ssed) Additionally, as shown in Table 22, there were clinically significant improvements in favor of the Symfony IOL with 76.9% (113/147) and 70.1% ( ...