An interventional study of FluidVision AIOL and Cataract Surgery in Aphakia, sponsored by PowerVision. Completed at 8 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-05-21.
Sponsored by PowerVision · Not applicable, Interventional, and Device feasibility
The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.
Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 170 is above the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →PowerVision is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery
Device: FluidVision AIOL · Procedure: Cataract Surgery
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Performed using standard microsurgical techniques
Accommodative amplitude
Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near.
Time frame: Month 6
Best corrected distance visual acuity (BCDVA)
Visual acuity of the eye will be tested with the correction in place.
Time frame: Month 6
Rates of adverse events
Adverse events will be collected from time of enrollment to study exit
Time frame: Up to Month 36
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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