Vision Eye Institute
Footscray, Victoria, 3011, Australia
NCT Number: NCT03027024
This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Footscray, Victoria, 3011, Australia
Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Other names: PhysIOL HP
Time frame: 3 months postoperative
measured in logMAR
Time frame: 3 months postoperative
measured in logMAR
Time frame: 3 months postoperative
measured in logMAR
Time frame: 3 months postoperative
measured in logMAR
Time frame: 3 months postoperative
measured in logMAR
Time frame: 3 months postoperative
measured in logMAR
Time frame: 3 months postoperative
measured in logMAR
Time frame: 3 months postoperative
measured in logCS
Beaver-Visitec International, Inc.
Industry
Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP
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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