Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
This trial is active, not recruiting.
|Treatment||acrysof® iq panoptix™ presbyopia-correcting iol|
|Start date||September 2015|
|End date||December 2016|
|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.
|Intervention model||single group assignment|
Mean Binocular Defocus Visual Acuity (VA)
time frame: Up to Day 120-180 from second eye implantation
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.
|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.|
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