Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction
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Phase
Not applicable
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
304actual
Sites
16
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-07 | actual | When the study began enrolling |
| Primary completion | 2026-06-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-11 | actual | The whole study's end, after follow-up |
| First posted | 2024-03-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Cataract
Interventions
- Device: enVista Beyond EY (EDF) IOL
- Device: enVista MX60E monofocal IOL
Primary outcomes
what the primary-completion date above is the date OFMean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.
measured Day 120 to Day 180 after second eye implantation
Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.
measured Day 120 to Day 180 after second eye implantation
Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4.
measured Day 120 to Day 180 after second eye implantation
Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4.
measured Day 120 to Day 180 after second eye implantation
Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4.
measured Day 120 to Day 180 after second eye implantation
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