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Intraocular Lens

Symfony IOL for Cataract

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Binocular distance corrected intermediate visual acuity at 66 cm under mesopic conditions.

Secondary outcome measures

Binocular distance corrected intermediate visual acuity at 40 cm under mesopic conditions.

Binocular low contrast distance visual acuity under mesopic conditions

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carolina Eyecare Physicians, LLCLead Sponsor

10 Previous Clinical Trials

548 Total Patients Enrolled

7 Trials studying Cataract

452 Patients Enrolled for Cataract

Science in VisionOTHER

16 Previous Clinical Trials

752 Total Patients Enrolled

11 Trials studying Cataract

534 Patients Enrolled for Cataract

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to actively enroll participants for this clinical trial?

"Indeed, as per the details available on clinicaltrials.gov, this ongoing clinical trial is actively seeking participants. The trial was initially posted on December 1st, 2023 and recently updated on January 19th, 2024. The study aims to recruit a total of 64 patients from two designated sites."

Answered by AI

Has the Symfony intraocular lens (IOL) received approval from the FDA?

"Due to the approval of Symfony IOL, this Phase 4 trial has been assigned a safety rating of 3 by our team at Power."

Answered by AI

What is the overall count of individuals participating in this clinical study?

"Indeed, according to the information provided on clinicaltrials.gov, this investigation is presently in the process of actively recruiting eligible individuals. The study was initially posted on December 1st, 2023 and underwent its most recent revision on January 19th, 2024. In total, there is a need for 64 participants who will be enrolled across two distinct research locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Symfony vs Vivity in Dim Light

2023. "Symfony vs Vivity in Dim Light". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229106.

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