This trial is active, not recruiting.

Condition cataract
Treatment acrysof® iq panoptix™ presbyopia-correcting iol
Sponsor Alcon Research
Start date September 2015
End date June 2017
Trial size 167 participants
Trial identifier NCT02529488, ILH297-P002


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
acrysof® iq panoptix™ presbyopia-correcting iol Model TFNT00
Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Primary Outcomes

Mean Binocular Defocus Visual Acuity (VA)
time frame: Up to Day 120-180 from second eye implantation

Eligibility Criteria

Male or female participants at least 22 years old.

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.

Additional Information

Official title Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00
Description This study will be conducted in regions where the test article is approved at the time of study start.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alcon Research.