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

Not Applicable

Not yet recruiting

• Conditions: Cataract
• Interventions: Device: Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL

• Registration Number: NCT06500416
• Lead Sponsor: Coastal Eye Surgeons PLLC

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-15
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL	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.

Primary Outcome Measures

Name	Time	Method
Binocular uncorrected visual acuity at distance	3 months	Mean binocular uncorrected visual acuity at distance
Binocular uncorrected visual acuity at near	3 months	Mean binocular uncorrected visual acuity at near
Binocular uncorrected visual acuity at intermediate	3 months	Mean binocular uncorrected visual acuity at intermediate

Trial Locations

Locations (1)

Coastal eye surgeons; 🇺🇸 Greenwich, Connecticut, United States