The Eye in Orbit: UCF Adaption

The Eye in Orbit- Analysis of the Anatomical and Functional Ocular Changes Related to Space Flights: UCF Adaptation.

The goal of this study is to understand the impact of space travel on the eyes. Space flight impacts numerous aspects of ocular anatomy and physiology. Current hypotheses are based on pressure changes within and around the optic nerve. Retinal and choroid blood drainage may be affected by microgravity associated cerebrospinal fluid pressure changes. Recently, a new imaging modality, Optical Coherence Tomography Angiography (OCTA), has been able to reveal micro vascular changes in the retina and choroid. To date, no microgravity ocular imaging tests have been published using OCTA. In this study the researchers aim to describe microgravity circadian choroidal and retinal vasculature using multimodal imaging including OCTA to better understand space associated ocular changes.

Study Overview

• Status: Completed
• Conditions: Spaceflight Associated Neuro-Ocular Syndrome; SANS

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study necessarily had a very specific population. The study only enrolled astronauts in the AX1/Rakia mission, which was scheduled for space flight in late March 2022.

Description

Inclusion Criteria:

- astronauts in the AX1/Rakia mission, which was scheduled for space flight in late March 2022.

Exclusion Criteria:

• adults unable to consent
• individuals who are not yet adults (infants, children, teenagers) -
• pregnant women
• prisoners.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To examine early changes in ocular physiology following exposure to microgravity and asses these changes as risk factor for Spaceflight Associated Neuro-Ocular Syndrome (SANS).	4 months
Asses early changes in ocular physiology as risk factor for Spaceflight Associated Neuro-Ocular Syndrome (SANS).	4 months

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Mehul Patel, MD, MSc, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: OCTA; Optical Coherence Tomography Angiography; SANS; Space; Spaceflight Associated Neuro-Ocular Syndrome; Astronaut
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: STUDY00003845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No