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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.

• Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF and authorization as appropriate for local privacy regulations.

• Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a glare source present (Brightness Acuity Tester), or have significant cataract-related visual symptoms, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.

• Subjects must have preoperative corneal astigmatism less than 1.0 D for each eye.

• Subjects must have a BCDVA projected to be better than 20/30 after cataract removal and IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary.

• Subjects must have clear intraocular media other than the cataract in both eyes.

• Contact lens wearers must demonstrate a stable refraction (within ±0.50 D in magnitude for both sphere and cylinder and within ±15° in axis) in both eyes, as determined by distance manifest refraction on two consecutive examination dates (both refractions performed at least 7 days apart) after discontinuation of contact lens wear (Rigid or Toric lenses discontinued for at least 2 weeks and soft contact lenses discontinued for at least 3 days prior to the first refraction used to establish stability and through the day of surgery).

• Subjects must require an IOL power from +14.0 diopter (D) to +28.0 D for each eye.

• Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures, and to undergo second eye surgery within 7-30 days of the first eye surgery.

Locations
United States
Alabama
Site 119
RECRUITING
Dothan
California
Site 108
RECRUITING
Northridge
Minnesota
Site 116
RECRUITING
Alexandria
Site 107
ACTIVE_NOT_RECRUITING
Bloomington
North Dakota
Site 118
RECRUITING
West Fargo
Nebraska
Site 101
RECRUITING
Omaha
Nevada
Site 109
RECRUITING
Las Vegas
New York
Site 113
RECRUITING
Garden City
Ohio
Site 102
RECRUITING
Brecksville
South Carolina
Site 105
RECRUITING
North Charleston
South Dakota
Site 106
RECRUITING
Sioux Falls
Texas
Site 103
RECRUITING
Dallas
Site 112
RECRUITING
San Antonio
Site 117
RECRUITING
San Antonio
Site 115
RECRUITING
Sugar Land
Wisconsin
Site 111
RECRUITING
Mount Pleasant
Contact Information
Primary
Jennifer Laskowski
Jennifer.Laskowski@bausch.com
818-369-9137
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2026-07
Participants
Target number of participants: 299
Treatments
Experimental: enVista Beyond EY IOL
Subjects implanted with enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY
Active_comparator: enVista MX60E monofocal IOL
Subjects implanted with enVista MX60E monofocal IOL
Related Therapeutic Areas
Sponsors
Leads: Bausch & Lomb Incorporated

This content was sourced from clinicaltrials.gov