NCT05624398

Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery

Visual Outcomes and Patient Satisfaction in Subjects With Stable Open-angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery and IOL Implantation With an Extended-depth-of-focus IOL

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Vold Vision P.L.L.C · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine how well patients with glaucoma can see following cataract surgery with a special type of lens called an extended-depth-of-focus (EDOF) lens. This lens is intended to reduced the patients need for glasses following cataract surgery. Patients will also undergo a minimally invasive type of glaucoma surgery using a special type of stent to reduce eye pressure, with the goal of better glaucoma control and the reduction in the need for medications to control eye pressure.

Detailed description

To evaluate the range of vision and patient reported outcomes in subjects implanted with Clareon Vivity IOL undergoing concurrent MIGS with the Hydrus Microstent

Conditions

• Glaucoma, Open-Angle
• Cataract

Interventions

Type	Name	Description
DEVICE	Vivity IOL	Cataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent

Timeline

• Start date: 2022-12-07
• Primary completion: 2025-02-01
• Completion: 2025-05-01
• First posted: 2022-11-22
• Last updated: 2024-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study