Symfony Intraocular Lens Retrospective Chart Review

Sponsor

Austin Eye (Other)

Overall Status

Completed

CT.gov ID

NCT05111106

Collaborator

Johnson & Johnson (Industry)

463

Enrollment

26.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Symfony IOL

Detailed Description

This was a retrospective chart review conducted at a single US clinical site. Chart review was conducted by John Odette, MD and research assistants. Eligible charts were identified via a clinic database search of cataract surgeries with IOL implantation of the Symfony IOL during the stated date range. Eligible charts included those of patients 18 to 90 years of age who underwent Femto Laser Assisted Cataract Surgery (FLACS) with implantation of a Symfony IOL. Charts were excluded for lack of postoperative follow-up or if Symfony IOL was not implanted. All qualifying patient charts were examined and further classified into 2 groups: (1) eyes with glaucoma; and 2) eyes without glaucoma. Visual acuity was evaluated for patients who underwent cataract surgery with implantation of the Symfony IOL from 09/1/2016 to 05/31/2018. Postoperative evaluations at Month 2 included mean monocular uncorrected visual acuity at near (UNVA) at 40 cm, far distance (UDVA) at 20 ft, and with best correction (CDVA). Outcomes were also compared for toric IOLs versus spherical IOL.

Study Design

Study Type:

Observational

Actual Enrollment :

463 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Experience With Symfony Extended Depth of Focus (EDOF) IOL: A Retrospective Chart Review

Actual Study Start Date :

Oct 5, 2016

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Non-Pathology Eyes Cataract Surgery with implantation of Symfony IOL in eyes without pre-existing pathology..	Device: Symfony IOL Implantation of Intraocular lens with extended depth of focus.
Glaucoma Eyes Cataract Surgery with implantation of Symfony IOL with pre-existing glaucoma.	Device: Symfony IOL Implantation of Intraocular lens with extended depth of focus.
Retinopathy Eyes Cataract Surgery with implantation of Symfony IOL in eyes with pre-existing retinal pathology..	Device: Symfony IOL Implantation of Intraocular lens with extended depth of focus.

Arm

Intervention/Treatment

Non-Pathology Eyes

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

Device: Symfony IOL

Implantation of Intraocular lens with extended depth of focus.

Glaucoma Eyes

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

Device: Symfony IOL

Implantation of Intraocular lens with extended depth of focus.

Retinopathy Eyes

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

Device: Symfony IOL

Implantation of Intraocular lens with extended depth of focus.

Outcome Measures

Primary Outcome Measures

Monocular uncorrected near visual acuity [2 months]
handheld near card (Jaeger scale)

Secondary Outcome Measures

Monocular best corrected distance visual acuity [2 months]
Snellen Chart at 20 feet

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

:Phacoemulsification cataract surgery with a Symfony IOL.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Austin Eye
Johnson & Johnson

Investigators

Principal Investigator: John Odette, Austin Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

John Odette, John Odette, MD, Austin Eye

ClinicalTrials.gov Identifier:

NCT05111106

Other Study ID Numbers:

AEJO-2018-Symfony

First Posted:

Nov 8, 2021

Last Update Posted:

Nov 8, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by John Odette, John Odette, MD, Austin Eye

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Nov 8, 2021