Symfony Intraocular Lens Retrospective Chart Review

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111106
• Other study ID #: AEJO-2018-Symfony
• Status: Completed
• Start date: October 5, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2021
• Source: Austin Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Symfony IOL
Implantation of Intraocular lens with extended depth of focus.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Austin Eye	Johnson & Johnson

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular uncorrected near visual acuity	handheld near card (Jaeger scale)	2 months
Secondary	Monocular best corrected distance visual acuity	Snellen Chart at 20 feet	2 months