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NCT06333015Not yet recruiting

Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction

A Prospective, Multicenter, Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction
Bausch & Lomb IncorporatedClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Cataract
Drug/Device/Intervention
enVista EY Beyond IOL
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Bausch & Lomb Incorporated
Location
Northridge,Bloomington,Omaha,Las Vegas,Brecksville,North Charleston,Sioux Falls,Dallas,Mount Pleasant,Calgary,Montréal, Canada,United States of America
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2024
End date
Oct 01, 2025
Enrollment
224 participants
Primary outcome

Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.,Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.,Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4.,Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4.,Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4.

Summary

This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb
 enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects
 who receive this IOL in both eyes.

ICD-10 classifications
Other cataractCataract, unspecifiedComplicated cataractOther specified cataractSenile cataract
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06333015
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06333015 through Pure Global AI's free database. This phase not specified trial is sponsored by Bausch & Lomb Incorporated and is currently Not yet recruiting. The study focuses on Cataract. Target enrollment is 224 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.