enVista MX60EFH trifocal intraocular lens (IOL) for Pseudoaphakia

N/A

Waitlist Available

Research Sponsored by Bausch & Lomb Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 120 to day 180 after second eye iol implantation

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of eye lens called the enVista trifocal intraocular lens. It is designed to help people see clearly at different distances after being implanted in the eye. The study focuses on patients who need a lens replacement, often due to cataracts.

Eligible Conditions

Pseudoaphakia
Cataract

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 120 to day 180 after second eye iol implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 120 to day 180 after second eye iol implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 120 to day 180 after second eye iol implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative Rate of Secondary Surgical Interventions Due to the Optical Properties of the Lens

Photopic Uncorrected Distance Visual Acuity (UDVA) for First Implanted Eyes

Photopic Uncorrected Near and Intermediate Visual Acuity (UNVA and UIVA) for First Implanted Eyes at 40 cm and 66 cm, Respectively

+2 more

Secondary study objectives

Change From Baseline ( Preoperative ) in Uncorrected Photopic Near and Intermediate Visual Acuity (UNVA and UIVA) at 40 cm and 66 cm, Respectively, for First Implanted Eyes to Post-Operative Visit 4

IOL Rotation for All Eyes at Post-Operative Visit 4

Incidence of Subjects Experiencing at Least One Severe Visual Disturbance

+3 more