An interventional study of Implantation of IOL: PhysIOL POD F GF in Cataract and Lens Opacity, sponsored by Beaver-Visitec International, Inc.. Completed at 1 site in Australia. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implantation of IOL: PhysIOL POD F GF
Device: Implantation of IOL: PhysIOL POD F GF
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Also known as: PhysIOL HP
binocular Distance Corrected Near Visual Acuity (DCNVA)
measured in logMAR
Time frame: 3 months postoperative
monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
measured in logMAR
Time frame: 3 months postoperative
monocular and binocular Corrected Distance Visual Acuity (CDVA)
measured in logMAR
Time frame: 3 months postoperative
monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
measured in logMAR
Time frame: 3 months postoperative
monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
measured in logMAR
Time frame: 3 months postoperative
monocular and binocular Uncorrected Near Visual Acuity (UNVA)
measured in logMAR
Time frame: 3 months postoperative
monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)
measured in logMAR
Time frame: 3 months postoperative
Contrast Sensitivity (mesopic and photopic)
measured in logCS
Time frame: 3 months postoperative
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Beaver-Visitec International, Inc.