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Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction - Trial NCT06333015

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.

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Trial Details
ClinicalTrials.govNCT06333015
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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

Study Focus

Cataract

enVista EY Beyond IOL

Interventional

device

Sponsor & Location

Bausch & Lomb Incorporated

Northridge,Bloomington,Omaha,Las Vegas,Brecksville,North Charleston,Sioux Falls,Dallas,Mount Pleasant,Calgary,Montréal, Canada,United States of America

Timeline & Enrollment

N/A

Apr 01, 2024

Oct 01, 2025

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 cataract
Cataract, unspecified
Complicated cataract
Other specified cataract
Senile cataract

Data Source

ClinicalTrials.gov

NCT06333015

Device Trial