Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure

NCT ID: NCT00471731

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-07

Study Completion Date

2014-11-13

Brief 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.

Detailed Description

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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.

Conditions

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Turner Syndrome Ovarian Failure, Premature Sex Chromosome Aberrations Menopause Perimenopause

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility 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 18 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- complaints of dry eye.
9. For age matched control population ONLY- oral contraceptives or menopausal hormone therapy or any medications which alter sex hormone levels in the blood or chronic usage of medications that induce dry eye.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janine A Clayton, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Eye Institute (NEI)

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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Smith JA, Vitale S, Reed GF, Grieshaber SA, Goodman LA, Vanderhoof VH, Calis KA, Nelson LM. Dry eye signs and symptoms in women with premature ovarian failure. Arch Ophthalmol. 2004 Feb;122(2):151-6. doi: 10.1001/archopht.122.2.151.

Reference Type BACKGROUND
PMID: 14769589 (View on PubMed)

Schaumberg DA, Buring JE, Sullivan DA, Dana MR. Hormone replacement therapy and dry eye syndrome. JAMA. 2001 Nov 7;286(17):2114-9. doi: 10.1001/jama.286.17.2114.

Reference Type BACKGROUND
PMID: 11694152 (View on PubMed)

Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.

Reference Type BACKGROUND
PMID: 3960433 (View on PubMed)

Other Identifiers

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07-EI-0145

Identifier Type: -

Identifier Source: secondary_id

070145

Identifier Type: -

Identifier Source: org_study_id

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