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Effect of Negative Pressure on Pattern Electroretinography Readings

Primary Purpose

Glaucoma, Open Angle, Low Risk, Ocular Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle
Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle
Sponsored by
Vance Thompson Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glaucoma focused on measuring glaucoma treatment, multi-pressure dial, pattern electroretinography, open-angle glaucoma

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects capable of committing to the duration of the study and signing the informed consent.
  • Subjects must be male or female and ≥ 22 years of age at the time of signing the informed consent.
  • Subjects with orbital anatomy that permits a proper seal when goggles are placed over eyes.
  • Subjects can tolerate ERG measurements.
  • Subjects with a documented BCVA OU 20/40 or better AND a diagnosis of OHT, glaucoma suspect, or OAG in both eyes. OAG definition is inclusive of normal tension glaucoma, pseudoexfoliation glaucoma, and pigment dispersion. Both eyes require same diagnosis.
  • Subjects with prior surgeries such as refractive surgeries (e.g., LASIK, PRK, SMILE), cataract surgery, cataract surgery with minimally invasive glaucoma surgery (MIGS), MIGS alone, trabeculectomy, or implantation of other glaucoma drainage devices can be included in the study; however, no other prior ocular surgeries are permitted.
  • Subjects without lenticular opacities and/or trace (i.e. 1+) lenticular opacities.

Exclusion Criteria:

  • Subjects with a history of allergy to primary study device material (i.e. silicone, anti-fog solution).
  • Subjects with a history of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or subject safety (e.g., corneal transplant).
  • Subjects with a history of any demyelinating disorder or condition that would likely interfere with the interpretation of the study results or subject safety (e.g. MS).
  • Subjects with an untreated retinal detachment, retinal tears, macular degeneration, or any other fundus findings that may prevent accurate ERG measurements in either eye.
  • Subjects with conjunctival chemosis in either eye.
  • Subjects with eyelid edema.
  • Subjects with a history of seizure disorder.
  • Subjects with an eye infection.
  • Subjects with moderate-severe (i.e. 2+, 3+, or 4+) lenticular opacities.

Sites / Locations

  • Vance Thompson VisionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Eye

Control Eye

Arm Description

10 mmHg of negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that only one goggle receives negative pressure.

The opposing eye serves as the intrasubject control for each participant. No negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that the other goggle does not receive negative pressure.

Outcomes

Primary Outcome Measures

Pattern Electroretinography (pERG) Alterations
Mercury™ MPD alters IOP in study eyes of subjects per controlled reduction of pressure. pERG changes induced by the Mercury™ MPD will provide insight into changes in retinal ganglion cells after wearing Mercury™ MPD with negative pressure applied anterior to the orbital rim.

Secondary Outcome Measures

Full Information

First Posted
June 11, 2020
Last Updated
September 30, 2020
Sponsor
Vance Thompson Vision
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1. Study Identification

Unique Protocol Identification Number
NCT04433702
Brief Title
Effect of Negative Pressure on Pattern Electroretinography Readings
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vance Thompson Vision

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open Angle, Low Risk, Ocular Hypertension, Glaucoma Suspect
Keywords
glaucoma treatment, multi-pressure dial, pattern electroretinography, open-angle glaucoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Eye
Arm Type
Experimental
Arm Description
10 mmHg of negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that only one goggle receives negative pressure.
Arm Title
Control Eye
Arm Type
Placebo Comparator
Arm Description
The opposing eye serves as the intrasubject control for each participant. No negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that the other goggle does not receive negative pressure.
Intervention Type
Device
Intervention Name(s)
Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle
Intervention Description
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: 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. Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device
Intervention Type
Device
Intervention Name(s)
Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle
Intervention Description
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: 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. Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device
Primary Outcome Measure Information:
Title
Pattern Electroretinography (pERG) Alterations
Description
Mercury™ MPD alters IOP in study eyes of subjects per controlled reduction of pressure. pERG changes induced by the Mercury™ MPD will provide insight into changes in retinal ganglion cells after wearing Mercury™ MPD with negative pressure applied anterior to the orbital rim.
Time Frame
0 hours; 4.5 hours; 6.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects capable of committing to the duration of the study and signing the informed consent. Subjects must be male or female and ≥ 22 years of age at the time of signing the informed consent. Subjects with orbital anatomy that permits a proper seal when goggles are placed over eyes. Subjects can tolerate ERG measurements. Subjects with a documented BCVA OU 20/40 or better AND a diagnosis of OHT, glaucoma suspect, or OAG in both eyes. OAG definition is inclusive of normal tension glaucoma, pseudoexfoliation glaucoma, and pigment dispersion. Both eyes require same diagnosis. Subjects with prior surgeries such as refractive surgeries (e.g., LASIK, PRK, SMILE), cataract surgery, cataract surgery with minimally invasive glaucoma surgery (MIGS), MIGS alone, trabeculectomy, or implantation of other glaucoma drainage devices can be included in the study; however, no other prior ocular surgeries are permitted. Subjects without lenticular opacities and/or trace (i.e. 1+) lenticular opacities. Exclusion Criteria: Subjects with a history of allergy to primary study device material (i.e. silicone, anti-fog solution). Subjects with a history of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or subject safety (e.g., corneal transplant). Subjects with a history of any demyelinating disorder or condition that would likely interfere with the interpretation of the study results or subject safety (e.g. MS). Subjects with an untreated retinal detachment, retinal tears, macular degeneration, or any other fundus findings that may prevent accurate ERG measurements in either eye. Subjects with conjunctival chemosis in either eye. Subjects with eyelid edema. Subjects with a history of seizure disorder. Subjects with an eye infection. Subjects with moderate-severe (i.e. 2+, 3+, or 4+) lenticular opacities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keeley Puls
Phone
6053717075
Email
keeley.puls@vancethompsonvision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Bleeker
Phone
6056309023
Email
adambkeeker@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Greenwood, MD
Organizational Affiliation
Vance Thompson Vision
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keeley Puls
Phone
605-371-7075
Email
keeley.puls@vancethompsonvision.com
First Name & Middle Initial & Last Name & Degree
Kristin Dunne
Phone
6053613937
Email
kristin.dunne@vancethompsonvision.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Negative Pressure on Pattern Electroretinography Readings

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