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Project Title:  Equinox Balance Goggles: The Effects of Local Orbital Pressure Changes on Intraocular Pressure Reduce
Fiscal Year: FY 2017 
Division: Human Research 
Research Discipline/Element:
Start Date: 10/01/2015  
End Date: 10/01/2016  
Task Last Updated: 03/10/2017 
Download report in PDF pdf
Principal Investigator/Affiliation:   Berdahl, John  M.D. / Equinox LLC 
Address:  3101 W. 57th Street 
 
Sioux Falls , SD 57108 
Email: john.berdahl@vancethompsonvision.com 
Phone: 949-632-4639  
Congressional District:
Web:  
Organization Type: INDUSTRY 
Organization Name: Equinox LLC 
Joint Agency:  
Comments:  
Project Information: Grant/Contract No. NCC 9-58-SMST00012 
Responsible Center: NSBRI 
Grant Monitor:  
Center Contact:   
Solicitation: NSBRI-RFA-SMARTCAP 
Grant/Contract No.: NCC 9-58-SMST00012 
Project Type: GROUND 
TechPort: No 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: None
Human Research Program Risks: None
Human Research Program Gaps: None
Task Description: ORIGINAL PROJECT AIMS/OBJECTIVES: To demonstrate safety and proof of concept of the Equinox Balance Goggle Device as follows - 1. The Equinox Balance Goggle Device reduces the pressure in the periorbital microenvironment anterior to the orbital rim. 2. The Equinox Balance Goggle Device is safe for use.

HYPOTHESES: 1. The Equinox Balance Goggle Device reduces the pressure in the microenvironment anterior to the orbital. 2. The Equinox Balance Goggle Device is safe for use as assessed by adverse events.

SPECIFIC AIMS: 1. Create the ability to manipulate pressure of the microenvironment of the orbit with the Balance Goggles with both pressure and vacuum microenvironments. 2. Prove that the optic nerve head morphology changes with increased pressure or vacuum to the microenvironment. 3. Determine that the Balance Goggles are safe for use with pressure and vacuum environments on the eye.

KEY FINDINGS: The safety of the Equinox Balance Goggle Device was demonstrated as a result of this study, with no reports of adverse events in the patient population. In this study, the Equinox Balance Goggles System was well-tolerated by the 30 patients enrolled and treated as part of the study protocol.

IMPACT OF FINDINGS: Integration of the Equinox Balance Goggle Device as part of NASA Space Programs or Projects may provide a method of mitigating the risk of spaceflight-induced intracranial hypertension/vision alterations through application of pressure in microenvironment directly in front of the eyes of astronauts.

PROPOSED RESEARCH PLAN FOR COMING YEAR: There is no additional research planned as part of this grant at this time.

 

Research Impact/Earth Benefits: Earth-based impacts and/or benefits of the research project are still unknown, and are the subject of other work being performed by Equinox LLC.

 

Task Progress & Bibliography Information FY2017 
Task Progress: Project complete; the task progress made during this funded grant year was completion of the intended safety study. See also Task Description/Summary.

 

Bibliography Type: Description: (Last Updated: 03/17/2017)  Show Cumulative Bibliography Listing
 
Articles in Peer-reviewed Journals Berdahl J. "The eye in space." US Ophthalmic Review. 2016;9(2):76-7. https://doi.org/10.17925/USOR.2016.09.02.76 , Sep-2016
Project Title:  Equinox Balance Goggles: The Effects of Local Orbital Pressure Changes on Intraocular Pressure Reduce
Fiscal Year: FY 2016 
Division: Human Research 
Research Discipline/Element:
Start Date: 10/01/2015  
End Date: 10/01/2016  
Task Last Updated: 01/22/2016 
Download report in PDF pdf
Principal Investigator/Affiliation:   Berdahl, John  M.D. / Equinox LLC 
Address:  3101 W. 57th Street 
 
Sioux Falls , SD 57108 
Email: john.berdahl@vancethompsonvision.com 
Phone: 949-632-4639  
Congressional District:
Web:  
Organization Type: INDUSTRY 
Organization Name: Equinox LLC 
Joint Agency:  
Comments:  
Project Information: Grant/Contract No. NCC 9-58-SMST00012 
Responsible Center: NSBRI 
Grant Monitor:  
Center Contact:   
Solicitation: NSBRI-RFA-SMARTCAP 
Grant/Contract No.: NCC 9-58-SMST00012 
Project Type: GROUND 
TechPort: No 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: None
Human Research Program Risks: None
Human Research Program Gaps: None
Task Description: The purpose of this study is to confirm the safety and efficacy of the Balance Goggles on humans when subjected to a change in pressure of the microenvironment of the eye. We will measure the safety of the Balance Goggles by measuring intraocular pressure (IOP), tear break up time (TBUT), refraction, keratometry, and performing a peripheral retinal exam both prior to pressure changes and after pressure changes. We will also measure optical coherence tomography (OCT) of the optic nerve prior, during, and after administering the change in orbital pressure to determine the ability of our device to change the morphology of the optic nerve head. Additionally we will assess qualitative measures such as comfort prior, during and after administration of the pressure change treatments.

 

Research Impact/Earth Benefits:

 

Task Progress & Bibliography Information FY2016 
Task Progress: New project for FY2016.

 

Bibliography Type: Description: (Last Updated: 03/17/2017)  Show Cumulative Bibliography Listing
 
 None in FY 2016