NCT04632329

Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma

Negative Pressure Applied by the Equinox Mercury™ Multi-Pressure Dial to Lower and Modulate Intraocular Pressure in Subjects With Severe Open Angle Glaucoma (The Ranger Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Equinox · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-significant risk, controlled, randomized, multi-center, masked, feasibility study to evaluate the safety and IOP-lowering effectiveness of negative pressure application (via the Mercury MPD) for lowering and titrating intraocular pressure (IOP) in severe open-angle glaucoma (OAG) patients. The study will be conducted at approximately three investigational sites in the United States. Between 60 and 100 subjects will be randomized to treatment. Treatment eyes will be administered two levels of negative pressure, calculated based on 50% and 75% of baseline IOP (as measured by pneumatonometry). One eye of each eligible subject will be randomized to receive negative pressure application with the MPD device; the contralateral eye will be used as a control and will be examined but will not undergo application of negative pressure. Subjects will be treated at each of the negative pressure levels for one hour. All study procedures will be conducted at one visit, and the subject will exit the study at the conclusion of the visit.

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DEVICE	Negative Pressure Treatment via the Mercury Multi-Pressure Dial	Negative Pressure Treatment via the Mercury Multi-Pressure Dial

Timeline

• Start date: 2020-10-28
• Primary completion: 2021-08-19
• Completion: 2021-08-19
• First posted: 2020-11-17
• Last updated: 2022-11-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study