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

NCT04632329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-11-10

No results posted yet for this study

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

DEVICE

Negative Pressure Treatment via the Mercury Multi-Pressure Dial

Negative Pressure Treatment via the Mercury Multi-Pressure Dial

Sponsors & Collaborators

  • Equinox

    lead INDUSTRY

Principal Investigators

  • Nate Radliffe, MD · New York Eye Surgery Center

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2021-08-19
Completion
2021-08-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632329 on ClinicalTrials.gov