NCT05583591

Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma

Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Diablo Eye Associates · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The goal of the study is to prospectively evaluate and compare Hydrus microstent to the iStent Inject Wide in combination with cataract surgery in patients with mild to moderate open angle glaucoma. Hydrus and iStent are the two FDA approved trabecular meshwork targeting microstents to treat open angle glaucoma in conjunction with cataract surgery.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Combined cataract surgery with Hydrus microstent	Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.
DEVICE	Combined cataract surgery with iStent Inject W	Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-04-22
• Completion: 2024-04-22
• First posted: 2022-10-17
• Last updated: 2024-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study