NCT05111106

Brief Summary

Retrospective chart review of patients with pre-existing ocular pathology who underwent cataract surgery with implantation of the Symfony IOL.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Status
completed

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

Study Start

First participant enrolled

October 5, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2.2 years

First QC Date

October 27, 2021

Last Update Submit

October 27, 2021

Conditions

Cataract

Keywords

Cataract surgeryGlaucomaRetinopathyIntraocular Lens

Outcome Measures

Primary Outcomes (1)

  • Monocular uncorrected near visual acuity

    handheld near card (Jaeger scale)

    2 months

Secondary Outcomes (1)

  • Monocular best corrected distance visual acuity

    2 months

Study Arms (3)

Non-Pathology Eyes

Cataract Surgery with implantation of Symfony IOL in eyes without pre-existing pathology..

Device: Symfony IOL

Glaucoma Eyes

Cataract Surgery with implantation of Symfony IOL with pre-existing glaucoma.

Device: Symfony IOL

Retinopathy Eyes

Cataract Surgery with implantation of Symfony IOL in eyes with pre-existing retinal pathology..

Device: Symfony IOL

Interventions

Symfony IOLDEVICE

Implantation of Intraocular lens with extended depth of focus.

Glaucoma EyesNon-Pathology EyesRetinopathy Eyes

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (18-90 years old) in need of cataract surgery.

You may qualify if:

  • :Phacoemulsification cataract surgery with a Symfony IOL.

You may not qualify if:

  • : Eyes not implanted with a Symfony IOL or unstable refractive results at final post-operative visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractGlaucomaRetinal Diseases

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesOcular Hypertension

Study Officials

  • John Odette

    Austin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
John Odette, MD

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 8, 2021

Study Start

October 5, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share