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Fiscal Year: FY 2017  Task Last Updated:  03/10/2017 
PI Name: Berdahl, John  M.D. 
Project Title: Equinox Balance Goggles: The Effects of Local Orbital Pressure Changes on Intraocular Pressure 
   
Division Name: Human Research 
Program/Discipline--
Element/Subdiscipline:
NSBRI--Smart Medical Systems and Technology Team 
 
Joint Agency Name:   TechPort:  No 
Human Research Program Elements: None
Human Research Program Risks: None
Human Research Program Gaps: None
Space Biology Element: None
Space Biology Cross-Element Discipline: None
Space Biology Special Category: None
PI Email: john.berdahl@vancethompsonvision.com  Fax:   
PI Organization Type: INDUSTRY  Phone: 949-632-4639  
Organization Name: Equinox LLC 
PI Address 1: 3101 W. 57th Street 
PI Address 2:  
PI Web Page:  
City: Sioux Falls  State: SD 
Zip Code: 57108  Congressional District: 
Comments:  
Project Type: GROUND  Solicitation:  NSBRI-RFA-SMARTCAP 
Start Date: 10/01/2015  End Date:  10/01/2016 
No. of Post Docs: No. of PhD Degrees: 
No. of PhD Candidates: No. of Master' Degrees: 
No. of Master's Candidates: No. of Bachelor's Degrees: 
No. of Bachelor's Candidates: Monitoring Center:  NSBRI 
Contact Monitor:   Contact Phone:   
Contact Email:  
Flight Program:  
Flight Assignment:

 

Key Personnel Changes/Previous PI:  
COI Name (Institution):  
Grant/Contract No.: NCC 9-58-SMST00012 
Performance Goal No.:  
Performance Goal Text:

 

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.

 

Rationale for HRP Directed Research:

 

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: 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
Download in PDF pdf     
Fiscal Year: FY 2016  Task Last Updated:  01/22/2016 
PI Name: Berdahl, John  M.D. 
Project Title: Equinox Balance Goggles: The Effects of Local Orbital Pressure Changes on Intraocular Pressure 
   
Division Name: Human Research 
Program/Discipline--
Element/Subdiscipline:
NSBRI--Smart Medical Systems and Technology Team 
 
Joint Agency Name:   TechPort:  No 
Human Research Program Elements: None
Human Research Program Risks: None
Human Research Program Gaps: None
Space Biology Element: None
Space Biology Cross-Element Discipline: None
Space Biology Special Category: None
PI Email: john.berdahl@vancethompsonvision.com  Fax:   
PI Organization Type: INDUSTRY  Phone: 949-632-4639  
Organization Name: Equinox LLC 
PI Address 1: 3101 W. 57th Street 
PI Address 2:  
PI Web Page:  
City: Sioux Falls  State: SD 
Zip Code: 57108  Congressional District: 
Comments:  
Project Type: GROUND  Solicitation:  NSBRI-RFA-SMARTCAP 
Start Date: 10/01/2015  End Date:  10/01/2016 
No. of Post Docs:   No. of PhD Degrees:   
No. of PhD Candidates:   No. of Master' Degrees:   
No. of Master's Candidates:   No. of Bachelor's Degrees:   
No. of Bachelor's Candidates:   Monitoring Center:  NSBRI 
Contact Monitor:   Contact Phone:   
Contact Email:  
Flight Program:  
Flight Assignment:

 

Key Personnel Changes/Previous PI:  
COI Name (Institution):  
Grant/Contract No.: NCC 9-58-SMST00012 
Performance Goal No.:  
Performance Goal Text:

 

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.

 

Rationale for HRP Directed Research:

 

Research Impact/Earth Benefits:

 

Task Progress: New project for FY2016.

 

Bibliography Type: Description: (Last Updated: 03/17/2017) Show Cumulative Bibliography Listing