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

Cataract Clinical Trial

Official title:

Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529488
• Other study ID #: ILH297-P002
• Status: Completed
• Phase: N/A
• Start date: September 7, 2015
• Est. completion date: June 26, 2017

Study information

• Verified date: March 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 26, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website