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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00471731
First received: May 9, 2007
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

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
Turner Syndrome
Ovarian Failure, Premature
Sex Chromosome Aberrations
Menopause
Perimenopause

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ocular Impact of X Chromosome Karyotype and Sex Hormones in Turner Syndrome

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 71
Study Start Date: May 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471731

Contacts
Contact: Angel H Garced, R.N. (301) 496-5847 garceda@mail.nih.gov
Contact: Janine A Clayton, M.D. (301) 402-1770 janine.clayton@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Janine A Clayton, M.D. National Eye Institute (NEI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00471731     History of Changes
Other Study ID Numbers: 070145, 07-EI-0145
Study First Received: May 9, 2007
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Ocular Surface Disease
Imprinting
Eye Abnormalities
Ovarian Insufficiency
Women's Eye Health and Disease
Turner Syndrome
TS
Premature Ovarian Failure
POF
Healthy Volunteer
HV

Additional relevant MeSH terms:
Chromosome Aberrations
Chromosome Disorders
Sex Chromosome Aberrations
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Gonadal Dysgenesis
Menopause, Premature
Primary Ovarian Insufficiency
Syndrome
Turner Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Disease
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Pathologic Processes
Urogenital Abnormalities

ClinicalTrials.gov processed this record on October 23, 2014