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Not yet recruiting NCT06500416

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

No phase Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Visual Outcomes Following Implantation of Tecnis Symfony Opti-Blue EDOF IOL in Patients With Mild to Moderate Retinal Ocular Comorbidities

Overview

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

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.

Interventions

  • Device 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.

Primary outcome measures

  • Binocular uncorrected visual acuity at distance [Time frame: 3 months]
  • Binocular uncorrected visual acuity at intermediate [Time frame: 3 months]
  • Binocular uncorrected visual acuity at near [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Coastal eye surgeons — Greenwich

Identifiers

NCT: NCT06500416 · CES/OS/01/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗