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NCT Number: NCT06500416

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL

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.

Primary outcomes

  1. Binocular uncorrected visual acuity at distance

    Time frame: 3 months

    Mean binocular uncorrected visual acuity at distance

  2. Binocular uncorrected visual acuity at intermediate

    Time frame: 3 months

    Mean binocular uncorrected visual acuity at intermediate

  3. Binocular uncorrected visual acuity at near

    Time frame: 3 months

    Mean binocular uncorrected visual acuity at near

Other outcomes

  1. Monocular uncorrected visual acuity at distance

    Time frame: 3 months

    Mean monocular uncorrected visual acuity at distance

  2. Monocular corrected visual acuity at distance

    Time frame: 3 months

    Mean monocular corrected visual acuity at distance

  3. Monocular uncorrected visual acuity at intermediate

    Time frame: 3 months

    Mean monocular uncorrected visual acuity at intermediate

  4. Monocular distance-corrected visual acuity at intermediate

    Time frame: 3 months

    Mean monocular distance corrected visual acuity at intermediate

  5. Monocular uncorrected visual acuity at near

    Time frame: 3 months

    Mean monocular uncorrected visual acuity at near

  6. Monocular distance-corrected visual acuity at near

    Time frame: 3 months

    Mean monocular distance corrected visual acuity at near

  7. Binocular corrected visual acuity at distance

    Time frame: 3 months

    Mean binocular corrected visual acuity at distance

  8. Binocular distance-corrected visual acuity at intermediate

    Time frame: 3 months

    Mean binocular distance-corrected visual acuity at intermediate

  9. Binocular distance-corrected visual acuity at near

    Time frame: 3 months

    Mean binocular distance-corrected visual acuity at near

Study contacts

Contact information is provided by the study sponsor or research team.

Martha Kaczynski

CONTACT

[email protected]

203-919-2253

Omar Shakir, MD, MBA

CONTACT

[email protected]

321-960-2664

Sponsors and collaborators

Lead sponsor

Coastal Eye Surgeons PLLC

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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