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The Eye in Orbit: UCF Adaption

Sponsor
University of Central Florida (Other)
Overall Status
Completed
CT.gov ID
NCT06092359
Collaborator
(none)
1
Enrollment
1
Location
5
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Eye in Orbit- Analysis of the Anatomical and Functional Ocular Changes Related to Space Flights: UCF Adaptation.
    Actual Study Start Date :
    Mar 1, 2022
    Actual Primary Completion Date :
    Jul 31, 2022
    Actual Study Completion Date :
    Jul 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Asses early changes in ocular physiology as risk factor for Spaceflight Associated Neuro-Ocular Syndrome (SANS). [4 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • astronauts in the AX1/Rakia mission, which was scheduled for space flight in late March
    Exclusion Criteria:

    • adults unable to consent

    • individuals who are not yet adults (infants, children, teenagers) -

    • pregnant women

    • prisoners.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Central Florida Orlando Florida United States 32816

    Sponsors and Collaborators

    • University of Central Florida

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Central Florida
    ClinicalTrials.gov Identifier:
    NCT06092359
    Other Study ID Numbers:
    • STUDY00003845
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Central Florida
    SANS
    Spaceflight Associated Neuro-Ocular Syndrome
    Optical Coherence Tomography Angiography
    OCTA
    Space
    Astronaut
    Additional relevant MeSH terms:
    Syndrome

    Study Results

    No Results Posted as of Oct 23, 2023