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NCT02896452 · ClinicalTrials.gov registry record
Astronaut Vision Issues in a Ground Analog Population: Polycystic Ovary Syndrome
A clinical trial of Polycystic Ovarian Syndrome and Idiopathic Intracranial Hypertension, sponsored by National Aeronautics and Space Administration.
- Active
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT02896452: Active study of Polycystic Ovarian Syndrome and Idiopathic Intracranial Hypertension, sponsored by National Aeronautics and Space Administration.
NCT02896452 is a study of Polycystic Ovarian Syndrome and Idiopathic Intracranial Hypertension that is active but no longer recruiting, run by National Aeronautics and Space Administration. The registered enrollment target is 60 participants, above the 29-participant average among 4 other Polycystic Ovarian Syndrome trials with a reported enrollment target (107% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02896452, a study of Polycystic Ovarian Syndrome and Idiopathic Intracranial Hypertension, is active but no longer recruiting, sponsored by National Aeronautics and Space Administration.
- ACTIVE NOT RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
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 Studied
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-10-01 |
| Est. Completion | 2026-09 |
What the registry record for NCT02896452 still lists
NCT02896452 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 29-participant average among 4 other Polycystic Ovarian Syndrome trials with a reported enrollment target (107% higher).
The record links to 2 conditions, with Polycystic Ovarian Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT02896452 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02896452 about?
NCT02896452 is a clinical study titled "Astronaut Vision Issues in a Ground Analog Population: Polycystic Ovary Syndrome". 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: ...
What is the current status of trial NCT02896452?
This trial is currently active not recruiting. The enrollment target is 60 participants. The study started on 2016-10-01. Estimated completion is 2026-09.
What conditions does trial NCT02896452 study?
This clinical trial studies the following conditions: Polycystic Ovarian Syndrome, Idiopathic Intracranial Hypertension.
Who is sponsoring clinical trial NCT02896452?
This trial is sponsored by National Aeronautics and Space Administration, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02896452 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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