Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

• Registration Number: NCT02529488
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

Detailed Description

This study will be conducted in regions where the test article is approved at the time of study start.

Study Timeline

• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Study Start: 2015-09-07
• Primary Completion: 2016-11-30
• Study Completion: 2017-06-26
• Status Verified: 2018-03
• Results First Submitted: 2018-03-08
• Results First Submitted QC: 2018-03-08
• Results First Posted: 2018-04-06
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

• Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
• Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
• Clear intraocular media other than cataract in both eyes;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
• Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
• Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
• Pregnant or lactating;
• Expected to require ocular surgical or retinal laser treatment;
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TFNT00	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

Primary Outcome Measures

Name	Time	Method
Mean Binocular Defocus Visual Acuity (VA)	Day 20-40 and Day 120-180 from second eye implantation	Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.