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OpenTrials
Completed

NCT Number: NCT05111106

Symfony Intraocular Lens Retrospective Chart Review

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

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Key information

Conditions

Cataract Eye Diseases Glaucoma Lens Diseases Ocular Hypertension Retinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symfony IOL

Device

Implantation of Intraocular lens with extended depth of focus.

Primary outcomes

  1. Monocular uncorrected near visual acuity

    Time frame: 2 months

    handheld near card (Jaeger scale)

Secondary outcomes

  1. Monocular best corrected distance visual acuity

    Time frame: 2 months

    Snellen Chart at 20 feet

Sponsors and collaborators

Lead sponsor

Austin Eye

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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