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

NCT00471731 | Completed

• 2 other identifiers: 07014507-EI-0145
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Turner Syndrome; Ovarian Failure, Premature; Sex Chromosome Aberrations; Menopause; Perimenopause

Keywords

Ocular Surface Disease; Imprinting; Eye Abnormalities; Ovarian Insufficiency; Women's Eye Health and Disease; Turner Syndrome; TS; Premature Ovarian Failure; POF; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 14769589 BACKGROUND

• 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.

  PMID: 11694152 BACKGROUND

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

  PMID: 3960433 BACKGROUND

MeSH Terms

Conditions

Turner Syndrome; Primary Ovarian Insufficiency; Sex Chromosome Aberrations; Eye Abnormalities; Disease

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Eye Diseases

Study Officials

• Janine A Clayton, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2007
• First Posted: May 10, 2007
• Study Start: May 7, 2007
• Study Completion: November 13, 2014
• Last Updated: February 14, 2018

Record last verified: 2014-11-13

Locations

US (1)