Symfony Intraocular Lens Retrospective Chart Review

October 27, 2021 updated by: John Odette, Austin Eye

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monocular uncorrected near visual acuity
Time Frame: 2 months
handheld near card (Jaeger scale)
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monocular best corrected distance visual acuity
Time Frame: 2 months
Snellen Chart at 20 feet
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austin Eye

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: John Odette, Austin Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEJO-2018-Symfony

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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