NCT06500416

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

July 9, 2024

Last Update Submit

August 7, 2024

Conditions

Cataract

Keywords

Retinal comorbidityTecnis Symfony Optiblue Intraocular Lens

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Monocular uncorrected visual acuity at distance

    3 months

  • Monocular corrected visual acuity at distance

    3 months

  • Monocular uncorrected visual acuity at intermediate

    3 months

  • +6 more other outcomes

Study Arms (1)

Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL

EXPERIMENTAL

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

Interventions

Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOLDEVICE

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.

Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coastal eye surgeons

Greenwich, Connecticut, 06830, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Omar Shakir, MD, MBA

CONTACT

321-960-2664omarshakir@coastaleyesurgeons.com

Martha Kaczynski

CONTACT

203-919-2253marthakacz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 15, 2024

Study Start

August 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)