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

Completed · Not applicable

Conditions studied: Glaucoma, Open-Angle

In brief

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.

Key facts

Study ID: NCT04632329
Run by: Equinox
People needed: 64
Starts: 2020-10-28
Expected to finish: 2021-08-19
Last updated by the study team: 2022-11-10

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects ≥ 22 years of age at the time of signing the informed consent
Subjects willing to sign the informed consent and capable of committing to the study assessments
Subjects with orbital anatomy that permits a proper seal in both eyes when goggles are placed over eyes and can obtain IOP measurements with Excursion goggles in place
Subjects with a diagnosis of severe open-angle glaucoma (OAG definition is inclusive of primary open angle glaucoma, normal tension glaucoma, pseudoexfoliative glaucoma, and pigmentary glaucoma) in at least one eye, defined by glaucomatous optic disc or RNFL abnormalities AND visual field abnormalities in both hemifields and/or loss within 5 degrees of fixation in at least one hemifield as tested with standard automated perimetry (the diagnosis of the contralateral eye may include suspected OAG< as well as mild/moderate/severe OAG)
Subjects with treatment regimens including current ocular hypotensive medications, prior non-incisional surgical procedures (e.g. MIGS and SLT), or any combination of the two
Subjects who are literate, able to speak English or Spanish, and able to understand and follow study instructions

You may not qualify if…

Subjects with a history of allergy to primary study device material (i.e., silicone and latex)
Subjects with a history of any ocular disorder or condition (e.g., corneal transplant) in either eye that would likely interfere with the interpretation of the study results or compromise subject safety
Subjects with a history of retinal tear/detachment, wet macular degeneration, diabetic macular edema, or proliferative diabetic retinopathy
Subjects with active conjunctival chemosis or anterior uveitis
Subjects with a Van Herick grade of 2 or less.
Subjects with a history of prior incisional filtering (i.e. trabeculectomy) or tube/shunt glaucoma surgery in either eye
Subjects with best corrected visual acuity of 20/200 or worse in either eye due to glaucoma
Subjects who do not wish to or cannot comply with study procedures

Where it is running

Illinois College of Optometry — Chicago, Illinois, United States
Vance Thompson Vision — Sioux Falls, South Dakota, United States
R and R Eye Research, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.