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

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00471731

Collaborator

(none)

Enrollment

Location

90.3

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Turner Syndrome Ovarian Failure, Premature Sex Chromosome Aberrations Menopause Perimenopause

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

72 participants

Time Perspective:

Prospective

Official Title:

Ocular Impact of X Chromosome Karyotype and Sex Hormones in Turner Syndrome

Study Start Date :

May 7, 2007

Study Completion Date :

Nov 13, 2014

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

Ability to understand and give informed consent.
Meet the diagnostic criteria for TS (45, X0) or premature ovarian failure OR age matched control for study participant with TS or POF.
For non Turner syndrome subjects only - Negative pregnancy test or post menopausal status for greater than or equal to 1 year.
Karyotype of XO for TS subjects or XX for POF and age matched control subjects.

EXCLUSION CRITERIA:

Persons less than 18 years old.
Persons with ophthalmic diseases associated with ocular surface disease.
Hyperprolactinemia.
Cushing s syndrome.
Other endocrine disorders which impact sex steroid hormones.
AIDS
Pregnancy or lactation.
For age matched control population ONLY- complaints of dry eye.
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.