NCT04433702

Effect of Negative Pressure on Pattern Electroretinography Readings

A Controlled, Open-Label, Randomized Study to Evaluate the Application of Negative Pressure to the Periocular Microenvironment to Alter Pattern Electroretinography Readings by Way of Modulating Intraocular Pressure

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vance Thompson Vision · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) remains the only modifiable risk factor for glaucoma. Without sufficient IOP lowering therapy, glaucoma induces retinal ganglion cell death and visual field loss. Pattern electroretinography (pERG) measurements directly correlate with retinal ganglion cell (RGC) signaling, providing an objective, repeatable, and non-invasive assessment of RGC function. The purpose of the study is to investigate the pERG changes associated with acute IOP reduction using the Mercury™ Multi-Pressure Dial (MPD). 10 patients will be enrolled. These subjects will have a best corrected visual acuity of 20/40 or better in both eyes and an established diagnosis of one of either mild/moderate OAG (open-angle glaucoma), OHT (ocular hypertension), or glaucoma suspect. Both eyes will be enrolled in the study. The study eye will receive a standardized 10 mmHg decrease in periorbital pressure via the Mercury™ Multi-Pressure Dial (MPD), and the fellow/control eye will receive no (zero) pressure application. Total google wear time will be 4.5 hours. Serial pERG measurements will be taken before, immediately after, and 2 hours after negative pressure application.

Conditions

• Glaucoma
• Open Angle, Low Risk
• Ocular Hypertension
• Glaucoma Suspect

Interventions

Type	Name	Description
DEVICE	Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle	The Mercury™ MPD applies negative pressure to one of the two goggles inducing an IOP reduction of 10 mmHg. This is randomized for each subject in the trial. The Mercury™ MPD consists of: 1. Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump. 2. Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device
DEVICE	Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle	The Mercury™ MPD applies no negative pressure to one of the two goggles eliciting no IOP reduction. This is randomized for each subject in the trial. The Mercury™ MPD consists of: 1. Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump. 2. Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device

Timeline

• Start date: 2020-10-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-06-16
• Last updated: 2024-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study