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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Tecnis Symfony Optiblue EDOF IOL is the latest version of Tecnis Symfony IOL with a violet light filter (VLF), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. The present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue IOL in patients with retinal comorbidities.

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 data supports the effectiveness of the Tecnis Symfony OptiBlue Lens for Cataracts treatment?

Research shows that the Tecnis Symfony lens, which is similar to the Tecnis Symfony OptiBlue, provides an extended range of vision for patients after cataract surgery, helping them see clearly at different distances. ^{1 2 3 4 5}

Is the Tecnis Symfony OptiBlue Lens safe for humans?

Research shows that the Tecnis Symfony intraocular lens, which is similar to the Tecnis Symfony OptiBlue, has been evaluated for safety in several studies. These studies generally report that the lens is safe for use in humans, with no major safety concerns identified. ^{2 6 7 8 9}

How is the Tecnis Symfony OptiBlue Lens treatment for cataracts different from other treatments?

The Tecnis Symfony OptiBlue Lens is unique because it is an extended depth-of-focus (EDOF) intraocular lens, which provides a continuous range of vision from near to far distances, reducing the need for glasses after cataract surgery. This lens design aims to improve vision quality by minimizing optical aberrations (distortions in vision) compared to traditional monofocal or multifocal lenses. ^{1 2 4 10 11}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Patient acceptability of the Tecnis multifocal intraocular lens. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Comparative Study of Two Extended Depth of Focus Intraocular Lenses. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

FOCUSED (Femtosecond Optimized Continuous Uncorrected Sight with EDOF and Diffractive Multifocal IOLs) - A Review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

European, Multicenter, Prospective, Non-comparative Clinical Evaluation of an Extended Depth of Focus Intraocular Lens. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the aspheric tecnis multifocal intraocular lens: one-year results from the first cohort of the food and drug administration clinical trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Extended depth of focus intraocular lenses for presbyopia. [2022]

10. China pubmed.ncbi.nlm.nih.gov

Comparison Between an Intraocular Lens With Extended Depth of Focus (Tecnis Symfony ZXR00) and a New Monofocal Intraocular Lens With Enhanced Intermediate Vision (Tecnis Eyhance ICB00). [2023]

11. India pubmed.ncbi.nlm.nih.gov

Optical aberrations in three different intraocular lens designs of a same platform. [2022]