Spaceflight Associated Neuro-Ocular SyndromeNCT06092359
The Eye in Orbit: UCF Adaption
An observational study of Spaceflight Associated Neuro-Ocular Syndrome and SANS, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spaceflight Associated Neuro-Ocular Syndrome, SANS
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- astronauts in the AX1/Rakia mission, which was scheduled for space flight in late March 2022.
Who cannot join
- adults unable to consent
- individuals who are not yet adults (infants, children, teenagers) -
- pregnant women
- prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: 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.
- Conditions
- Spaceflight Associated Neuro-Ocular Syndrome, SANS
- Keywords
- SANS, Spaceflight Associated Neuro-Ocular Syndrome, Optical Coherence Tomography Angiography, OCTA, Space, Astronaut
- Medical subject headings
- spaceflight-induced visual impairment
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
Asses early changes in ocular physiology as risk factor for Spaceflight Associated Neuro-Ocular Syndrome (SANS).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Mar 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spaceflight Associated Neuro-Ocular SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehul Patel, MD, MSc, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092359
- Sponsor's protocol ID
- STUDY00003845
- Status last verified
- Dec 2024
- First submitted
- 9 Oct 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Eye in Orbit- Analysis of the Anatomical and Functional Ocular Changes Related to Space Flights: UCF Adaptation.
- ClinicalTrials.gov ID
- NCT06092359
- Acronym / sponsor ID
- STUDY00003845
- Conditions
- Spaceflight Associated Neuro-Ocular Syndrome, SANS
- Keywords
- SANS, Spaceflight Associated Neuro-Ocular Syndrome, Optical Coherence Tomography Angiography, OCTA, Space, Astronaut
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- astronauts in the AX1/Rakia mission, which was scheduled for space flight in late March 2022.
Key exclusion criteria (4 listed)
- adults unable to consent
- individuals who are not yet adults (infants, children, teenagers) -
- pregnant women
- prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: 4 months
Asses early changes in ocular physiology as risk factor for Spaceflight Associated Neuro-Ocular Syndrome (SANS).
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehul Patel, MD, MSc principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spaceflight Associated Neuro-Ocular Syndrome and SANS, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.