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Symfony Intraocular Lens Retrospective Chart Review

NCT ID: NCT05111106

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

463 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-05

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cataract

Keywords

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Cataract surgery Glaucoma Retinopathy Intraocular Lens

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-Pathology Eyes

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

Symfony IOL

Intervention Type DEVICE

Implantation of Intraocular lens with extended depth of focus.

Glaucoma Eyes

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

Symfony IOL

Intervention Type DEVICE

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..

Symfony IOL

Intervention Type DEVICE

Implantation of Intraocular lens with extended depth of focus.

Interventions

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Symfony IOL

Implantation of Intraocular lens with extended depth of focus.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

Austin Eye

OTHER

Sponsor Role lead

Responsible Party

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John Odette

John Odette, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Odette

Role: PRINCIPAL_INVESTIGATOR

Austin Eye Center

Other Identifiers

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AEJO-2018-Symfony

Identifier Type: -

Identifier Source: org_study_id