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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar Shakir, MD, MBA; Phone Number: 321-960-2664; Email: omarshakir@coastaleyesurgeons.com
• Study Contact Backup: Name: Martha Kaczynski; Phone Number: 203-919-2253; Email: marthakacz@gmail.com

Study Locations

• United States
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Coastal Eye Surgeons
      • Contact: Omar Shakir, MD, MBA; Phone Number: 321-960-2664; Email: omarshakir@coastaleyesurgeons.com
      • Contact: Martha Kaczynski; Phone Number: 203-919-2253; Email: marthakacz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular uncorrected visual acuity at distance	Mean binocular uncorrected visual acuity at distance	3 months
Binocular uncorrected visual acuity at intermediate	Mean binocular uncorrected visual acuity at intermediate	3 months
Binocular uncorrected visual acuity at near	Mean binocular uncorrected visual acuity at near	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular uncorrected visual acuity at distance	Mean monocular uncorrected visual acuity at distance	3 months
Monocular corrected visual acuity at distance	Mean monocular corrected visual acuity at distance	3 months
Monocular uncorrected visual acuity at intermediate	Mean monocular uncorrected visual acuity at intermediate	3 months
Monocular distance-corrected visual acuity at intermediate	Mean monocular distance corrected visual acuity at intermediate	3 months
Monocular uncorrected visual acuity at near	Mean monocular uncorrected visual acuity at near	3 months
Monocular distance-corrected visual acuity at near	Mean monocular distance corrected visual acuity at near	3 months
Binocular corrected visual acuity at distance	Mean binocular corrected visual acuity at distance	3 months
Binocular distance-corrected visual acuity at intermediate	Mean binocular distance-corrected visual acuity at intermediate	3 months
Binocular distance-corrected visual acuity at near	Mean binocular distance-corrected visual acuity at near	3 months

Collaborators and Investigators

• Sponsor: Coastal Eye Surgeons PLLC

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Retinal comorbidity; Tecnis Symfony Optiblue Intraocular Lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CES/OS/01/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No