Clinical trial NCT06500416: Visual Outcomes of Tecnis Symfony Opti-Blue EDOF Intraocular Lens (IOL)
Official title: Visual Outcomes Following Implantation of Tecnis Symfony Opti-Blue EDOF IOL in Patients With Mild to Moderate Retinal Ocular Comorbidities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Keywords: Retinal comorbidity
Tecnis Symfony Optiblue Intraocular Lens
Lead sponsor: Coastal Eye Surgeons PLLC
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Binocular uncorrected visual acuity at distance
timeFrame: 3 months
measure: Binocular uncorrected visual acuity at intermediate
timeFrame: 3 months
measure: Binocular uncorrected visual acuity at near
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Monocular uncorrected visual acuity at distance
timeFrame: 3 months
measure: Monocular corrected visual acuity at distance
timeFrame: 3 months
measure: Monocular uncorrected visual acuity at intermediate
timeFrame: 3 months
measure: Monocular distance-corrected visual acuity at intermediate
timeFrame: 3 months
measure: Monocular uncorrected visual acuity at near
timeFrame: 3 months
measure: Monocular distance-corrected visual acuity at near
timeFrame: 3 months
measure: Binocular corrected visual acuity at distance
timeFrame: 3 months
measure: Binocular distance-corrected visual acuity at intermediate
timeFrame: 3 months
measure: Binocular distance-corrected visual acuity at near
timeFrame: 3 months
Locations:
city: Greenwich
country: United States
facility: Coastal eye surgeons
state: Connecticut
Study officials:
References: