Symfony Intraocular Lens Retrospective Chart Review

Completed

• Conditions: Cataract
• Interventions: Device: Symfony IOL

• Registration Number: NCT05111106
• Lead Sponsor: Austin Eye

Brief Summary

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

• Study Start: 2016-10-05
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2021-10
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Pathology Eyes	Symfony IOL	Cataract Surgery with implantation of Symfony IOL in eyes without pre-existing pathology..
Retinopathy Eyes	Symfony IOL	Cataract Surgery with implantation of Symfony IOL in eyes with pre-existing retinal pathology..
Glaucoma Eyes	Symfony IOL	Cataract Surgery with implantation of Symfony IOL with pre-existing glaucoma.

Primary Outcome Measures

Name	Time	Method
Monocular uncorrected near visual acuity	2 months	handheld near card (Jaeger scale)

Secondary Outcome Measures

Name	Time	Method
Monocular best corrected distance visual acuity	2 months	Snellen Chart at 20 feet