An interventional study of FluidVision AIOL and AcrySof IQ monofocal IOL in Cataract, sponsored by PowerVision. Completed. 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 objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.
This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 85 is close to the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →PowerVision is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated.
Device: FluidVision AIOL · Procedure: Cataract surgery
Implantation with the FluidVision AIOL in the first eye during cataract surgery, followed by implantation with the AcrySof IQ monofocal IOL in the fellow eye during a subsequent cataract surgery
Device: FluidVision AIOL · Device: AcrySof IQ monofocal IOL · Procedure: Cataract surgery
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Standard cataract extraction with phacoemulsification
Accommodative Amplitude (AA)
Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.
Time frame: Month 6 postoperative
Distance Corrected Visual Acuity
Visual acuity was measured with distance correction (plus or minus power) in place.
Time frame: Month 6 postoperative
International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL
Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.
Time frame: Up to Month 6 postoperative
Accommodative Amplitude
Accommodative amplitude is a measure of the range of vision with good acuity.
Time frame: Month 3 postoperative
Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity
Plus lenses were placed over the subject's best distance manifest correction.
Time frame: Up to Month 6 postoperative
Uncorrected Visual Acuity
Visual acuity was measured without correction in place.
Time frame: Up to Month 6 postoperative
No study locations are listed for this record.
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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