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Effect of Negative Pressure on Pattern Electroretinography Readings

NCT04433702 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-05-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Vance Thompson Vision

    lead OTHER

Principal Investigators

  • Michael Greenwood, MD · Vance Thompson Vision

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT04433702 on ClinicalTrials.gov