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OpenTrials
Completed

NCT Number: NCT02529488

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Device

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

Other names: Model TFNT00

Primary outcomes

  1. Mean Binocular Defocus Visual Acuity (VA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 20, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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