Visual Outcomes of Tecnis Symfony Opti-Blue EDOF Intraocular Lens (IOL)

NCT ID: NCT06500416

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Extended depth of focus (EDOF) IOLs, on the other hand, are based on the principle of creating a single-elongated focal point to enhance the depth of focus (DOF) and eliminate the overlapping of near and far images caused by traditional multifocal IOLs, thus generating a lower incidence of halos and glare. The Tecnis Symfony (Johnson \& Johnson Vision) EDOF IOL incorporates a diffractive echelette design to increase the range of vision. The achromatic technology corrects chromatic aberration and increases retinal image contrast.

The latest version of the Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts. As such, the present study aims to assess the visual outcomes at distance, intermediate and near following implantation of violet light filtering Tecnis Symfony Optiblue EDOF IOLs in patients with retinal comorbidities undergoing cataract surgery.

Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL

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.

Group Type EXPERIMENTAL

Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL

Intervention Type DEVICE

Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts.

Interventions

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Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL

Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with retinal comorbidities, with visual acuity potential of 20/30 or better, who wish to undergo bilateral cataract surgery and are willing to provide written informed consent and adhere to study requirements.

Exclusion Criteria

* Corneal dystrophies
* Central corneal scarring
* Keratoconus
* Proliferative diabetic retinopathy
* Exudative macular degeneration
* Zonular weakness
* Pseudoexfoliation
* Fovea-involving atrophy
* Severe dry eye
* Amblyopia
* Pupil abnormalities
* Need for an IOL outside the range of +5.0 D to +34.0 D or cylinder power over 3.75 D
* Patients who have undergone prior cataract surgery and IOL implantation in either eye; had prior corneal refractive or corneal transplantation surgery; diabetics post-vitrectomy; or who have a history of macula-off retinal detachment will also be excluded.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coastal Eye Surgeons PLLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Coastal eye surgeons

Greenwich, Connecticut, United States

Site Status

Countries

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United States

Central Contacts

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Omar Shakir, MD, MBA

Role: CONTACT

321-960-2664

Martha Kaczynski

Role: CONTACT

203-919-2253

Facility Contacts

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Omar Shakir, MD, MBA

Role: primary

321-960-2664

Martha Kaczynski

Role: backup

203-919-2253

Other Identifiers

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CES/OS/01/2023

Identifier Type: -

Identifier Source: org_study_id

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