Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure - NCT00471731-20892 (Clinical Trial 169741)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy169741.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Turner Syndrome - Ovarian Failure, Premature - Sex Chromosome Aberrations - Menopause - Perimenopause |
| Purpose: |
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Women with premature ovarian failure (POF) are at risk for dry eye. In addition, some women
with Turner syndrome (TS) report dry eye symptoms. This study will determine how many women
with TS have dry eye, compared to women with POF and women without these conditions.
Females 16 years of age and older with TS, POF, or neither of these conditions may be
eligible for this study. Participants undergo the following tests and procedures:
- Medical history: Subjects are asked about their current and previous medical conditions
and treatments they have had in the past. They complete forms with information about
how their eyes feel and if dry eye has bothered them.
- Assessment of tears and eye surface: The amount of tears the eyes can produce is
measured by placing a small piece of sterile paper in the corner of the eye for 5
minutes. Orange and green dyes are also placed in the eyes to determine the health of
the surface of the eye.
- Eye examination: Visual acuity (the ability to see the vision chart) and eye pressure
(fluid pressure in the eye) are measured. Pupils and eye movements are examined. The
structures inside the eye are examined through a microscope. The lens and retina (back
of the eye) are examined after drops have been placed in the eyes to widen the pupils.
The retina is examined with an ophthalmoscope (instrument with a strong light and
magnifying lens).
- Blood drawing: Blood samples are drawn through a needle in the arm to test for the
level of sex hormones.
- Conjunctival swab and tear fluid collection: A small sample of tears may be collected
in a small tube to study their consistency and makeup. The top layer of cells from the
surface of one eye may be removed with a swab or filter paper for study.
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| Study summary: |
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Premature ovarian failure (POF) is known to be associated with an increased risk of ocular
surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen
in this condition. From preliminary data, we suspect that women with Turners syndrome (45,
XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of
ocular surface disease. Comparing POF and TS women may allow us to distinguish different
mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen
and androgen) alterations posed by POF and TS. |
| Criteria: |
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- INCLUSION CRITERIA:
1. Ability to understand and give informed consent.
2. Meet the diagnostic criteria for TS (45, X0) or premature ovarian failure OR age
matched control for study participant with TS or POF.
3. For non Turner syndrome subjects only - Negative pregnancy test or post
menopausal status for greater than or equal to 1 year.
4. Karyotype of XO for TS subjects or XX for POF and age matched control subjects.
EXCLUSION CRITERIA:
1. Persons less than 16 years old.
2. Persons with ophthalmic diseases associated with ocular surface disease.
3. Hyperprolactinemia.
4. Cushing's syndrome.
5. Other endocrine disorders which impact sex steroid hormones.
6. AIDS
7. Pregnancy or lactation.
8. For age matched control population ONLY- oral contraceptives or menopausal hormone
therapy or any medications which alter sex hormone levels in the blood. |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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