← Back to Search

Intraocular Lens

Symfony vs Vivity Lenses for Cataracts

Phase 4

Recruiting

Research Sponsored by Carolina Eyecare Physicians, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU

Age: 50 years and older

Must not have

History of chronic intraocular inflammation

Any concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to compare two types of lenses used during cataract surgery. They will test how well these lenses improve vision in low light conditions. Participants will be asked to read a chart at different

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks associated with IOL implantation include inflammation, infection risk increase after surgery, potential for impaired vision due to lens dislocation or incorrect lens power.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am getting both my eye lenses replaced with EDOF implants aiming for perfect vision.

Select...

I am 50 years old or older.

Select...

My vision after surgery is expected to be quite good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of long-term eye inflammation.

Select...

I currently have an eye infection or inflammation.

Select...

I have had eye surgery before.

Select...

I have had LASIK, PRK, or RK eye surgery.

Select...

I chose not to have a certain eye lens implant because I was worried about seeing halos.

Select...

I suffer from severe dry eye.

Select...

I am not using any medication that affects my vision.

Select...

My diabetes is not under control.

Select...

I have had a retinal detachment in the past.

Select...

I have a serious eye condition before surgery.

Select...

I have no eye conditions like keratoconus that could affect my vision.

Select...

I have had a cornea transplant.

Select...

I have abnormal pupils.

Select...

I have a serious eye condition affecting the cornea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Symfony IOLActive Control1 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 IOLActive Control1 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.

0 / 17Eligibility criteria met