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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure | Experimental |
| |
| Control Eye | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Treatment via the Mercury Multi-Pressure Dial | Device | Negative Pressure Treatment via the Mercury Multi-Pressure Dial |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP* reduction of ≥ 20% with 50% Negative Pressure for the treatment group vs. the control group | Feasibility to lower intraocular pressure inside the eye in 1 treatment session (1-day). Not a measure of glaucoma progression health outcome. Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure. | Day 1 |
| Mean IOP*reduction with 50% Negative Pressure for the treatment group vs. the control group | Feasibility to lower intraocular pressure inside the eye in 1 treatment session (1-day). Not a measure of glaucoma progression health outcome. *Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| IOP* reduction of ≥ 25% with 75% Negative Pressure for the treatment group vs. the control group | *Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure | Day 1 |
| Mean IOP*reduction with 75% Negative Pressure for the treatment group vs. the control group |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Biomicroscopic Slit Lamp Findings | Slit lamp findings before and after negative pressure applications | Day 1 |
| Rate of ocular/periocular adverse events (% by adverse event) | Safety Outcomes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nate Radliffe, MD | New York Eye Surgery Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois College of Optometry | Chicago | Illinois | 60616 | United States | ||
| Vance Thompson Vision |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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*Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure |
| Day 1 |
| Day 1 |
| Corrected Distance Visual Acuity | Safety Outcomes | Day 1 |
| Sioux Falls |
| South Dakota |
| 57108 |
| United States |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | United States |