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

NCT02529488 | Completed Results FDA Device

• 1 other identifier: ILH297-P002
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Mean Binocular Defocus Visual Acuity (VA)

  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.

  Day 20-40 and Day 120-180 from second eye implantation

Study Arms (1)

TFNT00

EXPERIMENTAL

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Interventions

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL DEVICE

Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Also known as: Model TFNT00

TFNT00

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Global Brand Medical Affairs Lead, CDMA Surgical
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr Clinical Manager, Cataract

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: September 7, 2015
• Primary Completion: November 30, 2016
• Study Completion: June 26, 2017
• Last Updated: July 2, 2018
• Results First Posted: April 6, 2018

Record last verified: 2018-03