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Astronaut Vision Issues in a Ground Analog Population: Polycystic Ovary Syndrome

NCT02896452 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-05-22

No results posted yet for this study

Summary

The investigators have documented a genetic predisposition for some astronauts to develop ophthalmologic issues (e.g., choroidal folds, cotton wool spots, optic disc edema). Women with polycystic ovary syndrome (PCOS) have several characteristics similar to those described in astronauts, including: higher homocysteine concentrations, increased incidence of intracranial hypertension, increased retinal nerve fiber layer thickness, increased incidence of white matter hyperintensities on MRI, increased androgen concentrations (or androgen responses to space flight), and indices of altered carbohydrate metabolism. Women with PCOS have not been evaluated in detail regarding the occurrence of other anomalies observed in astronauts including choroidal folds, optic disc edema and cotton wool spots as well as changes in cycloplegic refraction, and optic nerve sheath diameter. While researchers have evaluated one-carbon metabolism pathway polymorphisms re: PCOS, and initial studies show an association with certain one-carbon polymorphisms, none have looked at the complete set of SNPs proposed here. This study will evaluate women with PCOS and/or idiopathic intracranial hypertension (IIH) to assess one-carbon biochemistry and genetics and their possible correlation with ophthalmologic findings. The investigators aim to clarify the relationship of one carbon metabolism and ophthalmic findings in astronauts and patients with PCOS and/or IIH.

Conditions

  • Polycystic Ovarian Syndrome
  • Idiopathic Intracranial Hypertension

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • Coastal Eye Associates

    collaborator UNKNOWN

  • National Aeronautics and Space Administration

    lead UNKNOWN

Principal Investigators

  • Scott M Smith, PhD · National Aeronautics and Space Administration (NASA)

  • Alice Y Chang, MD · Mayo Clinic

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2020-03-31
Completion
2026-09-30

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02896452 on ClinicalTrials.gov