Tecnis Symfony OptiBlue Lens for Cataracts

Overseen By Omar Shakir, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Coastal Eye Surgeons PLLC

Disqualifiers: Corneal dystrophies, Keratoconus, Diabetic retinopathy, others

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

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 tests a new lens implant for people with cataracts, particularly those with additional eye conditions like retinal issues. The lens, Tecnis Symfony OptiBlue, aims to enhance vision at all distances and reduce visual disturbances by filtering specific light wavelengths. Ideal candidates have cataracts and retinal comorbidities, seek improved vision, and have not undergone previous eye surgeries. As an unphased trial, this study provides an opportunity to advance eye care solutions for complex conditions.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Tecnis Symfony OptiBlue Lens is safe for cataract patients?

Research has shown that the Tecnis Symfony OptiBlue Intraocular Lens (IOL) is generally well-received by patients in previous studies. Users of this lens reported good results with few visual issues. Studies indicate that the lens enhances vision by blocking certain types of light, greatly improving clarity and comfort.

Additionally, comparisons of the Tecnis Symfony lens family, including the OptiBlue version, with other standard lenses have found it to be just as safe and often better for vision at middle distances. This means it helps people see clearly at various distances and is safe for use.

Overall, this lens has been tested in many trials and has a strong safety record. While this study phase does not provide new safety data, the lens's history in other studies and its ability to improve vision with minimal side effects make it a promising choice for those considering cataract surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Tecnis Symfony OptiBlue Lens is unique because it offers an extended depth of focus (EDOF) for those with cataracts, unlike traditional monofocal lenses that only improve vision at a single distance. This lens features a special OptiBlue filter, which enhances contrast by reducing glare and halos, common issues with existing multifocal lenses. Researchers are excited about this treatment because it promises to improve both near and distance vision with fewer visual disturbances, potentially offering a more seamless visual experience for cataract patients.

What evidence suggests that the Tecnis Symfony OptiBlue Lens is effective for cataracts?

Research has shown that the Tecnis Symfony OptiBlue Intraocular Lens (IOL), which participants in this trial will receive, greatly improves vision after cataract surgery. Patients often notice enhanced vision for distant objects and tasks at arm's length, such as reading a computer screen. Compared to regular lenses, the Symfony IOL reduces the need for glasses at various distances. Some patients have reported seeing halos (rings of light) around lights, but many find their overall vision quality excellent. Previous studies suggest that this lens offers a good balance of clear vision at different distances. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing cataract surgery who wish to improve their vision at various distances. It's specifically testing a new type of lens implant that filters certain light wavelengths. Patients with additional eye conditions affecting the retina may also participate.

Inclusion Criteria

I have eye conditions but can see well enough and agree to follow study rules for cataract surgery.

Exclusion Criteria

I have weak eye ligaments.

I have been diagnosed with keratoconus.

I have a severe form of diabetic eye disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo femtosecond laser-assisted cataract surgery with implantation of the Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL in both eyes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue IOL

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tecnis Symfony OptiBlue EDOF Intraocular Lens

Trial Overview

The study is evaluating the Tecnis Symfony OptiBlue and its toric version, which are advanced lens implants designed to enhance vision after cataract removal by filtering violet light and reducing visual disturbances.

How Is the Trial Designed?

Group I: Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL Experimental Treatment 1 Intervention

This prospective, non-comparative, interventional study will include 15 cataract patients (30 eyes) who will undergo femtosecond laser-assisted cataract surgery with implantation of the Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL in both eyes.

Who Is Running the Clinical Trial?

Coastal Eye Surgeons PLLC

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

The Mini Well Ready extended depth of focus (EDOF) intraocular lens (IOL) demonstrated good visual acuity across different distances, with 95.31% of patients achieving a fluent reading speed of 80 words per minute without needing distance correction.

The lens provided enhanced contrast sensitivity and had a low incidence of photic phenomena, with only one reported case of moderate photophobia, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European, Multicenter, Prospective, Non-comparative Clinical Evaluation of an Extended Depth of Focus Intraocular Lens. Auffarth, GU., Moraru, O., Munteanu, M., et al.[2021]

The Tecnis(®) Multifocal Intraocular Lens is designed to enhance vision quality and reduce spherical aberration, aiming to provide patients with a broader range of focus after cataract surgery.

This lens design reflects the growing demand for presbyopia-correcting solutions, highlighting its potential to help patients achieve spectacle independence, which is a key goal in modern cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient acceptability of the Tecnis multifocal intraocular lens. Sood, P., Woodward, MA.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05541796

Clinical Outcomes Following Implantation of Tecnis ...

Thus, the present study aims to evaluate the clinical outcomes and patient satisfaction following implantation of a combination of Tecnis Synergy and Tecnis ...

2.

pmc.ncbi.nlm.nih.gov

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

Assessing Visual Outcomes: A Comparative Study of US- ...

This study compares the efficacy, safety, and patient-reported outcomes of three intraocular implants (IOL): Tecnis Synergy IOL, AcrySof IQ ...

3.

trial.medpath.com

trial.medpath.com/clinical-trial/43bac38f3fabfd3e/nct03082599-visual-outcomes-edof-intraocular-lens

Symfony Toric Intraocular Lens Visual Outcomes | MedPath

Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% ...

4.

crstoday.com

crstoday.com/articles/tecnis-symfony-optiblue-iol-with-intelilight/tecnis-symfony-optiblue-iol-with-intelilight-2

TECNIS Symfony ™ OptiBlue ™ IOL with InteliLight

While the quality of vision reported by patients after implantation with TECNIS Symfony™ IOL was excellent, some patients reported dysphotopsias such as halos ...

5.

withpower.com

withpower.com/trial/phase-cataract-7-2024-b4088

Tecnis Symfony OptiBlue Lens for Cataracts

The present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11564627/

Clinical Evaluation of Violet Light Filtration and High ...

The purpose of this study is to measure the subjective and objective clinical performance of the Tecnis Symfony Optiblue IOL, with the violet ...

7.

researchgate.net

researchgate.net/publication/353312003_Visual_outcomes_and_safety_of_the_TECNIS_Symfony_intraocular_lens_results_of_a_pivotal_clinical_trial

(PDF) Visual outcomes and safety of the TECNIS Symfony ...

Purpose: To compare the effectiveness and safety of the TECNIS Symfony® intraocular lens (IOL; ZXR00) with the TECNIS® 1-piece monofocal IOL ...

8.

jnj.com

jnj.com/media-center/press-releases/johnson-johnson-vision-introduces-all-purpose-edof-tecnis-symfony-optiblue-iol-the-latest-pc-iol-powered-by-intelilight-technology

The TECNIS PC-IOL Portfolio Powered by InteliLight ...

This extended depth-of-focus (EDOF) lens expands presbyopia correction to more patients and joins TECNIS Synergy IOL, a high-performance hybrid lens designed ...