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Tissue Studies of Human Eye Diseases

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier:
NCT00001310
First received: November 3, 1999
Last updated: April 21, 2017
Last verified: September 16, 2015
  Purpose

The purpose of this project is to diagnose and evaluate ocular and related tissues with various diseases such as conjunctival, corneal, uveal, vitreoretinal and optic nerve disorders, ocular degenerative, metabolic or genetic diseases and tumors. These will be studied using light microscopy, electron microscopy, confocal microscopy, immunohistochemistry, molecular pathological including polymerase chain reaction and in situ hybridization, as well as measuring the functions of cellular organelles, e.g., mitochondrial function. Lymphocytes in the peripheral blood as well as other involved biopsied tissues and ocular tissue will be compared and categorized by disease. Cytokines, chemokines or growth factors and/or other released molecules in the blood and ocular fluids will be also analyzed. Elucidating the relationship between the infiltrating cells, ocular resident cells, and their products in various diseases will help us to make diagnoses and increase our understanding of human ocular disorders.

Patients who require eye surgery to treat an eye disease or other disease in which the eye is involved may participate in this study. Samples of eye tissue and fluid that are normally removed and discarded during eye surgery will instead be given to researchers for study. The tissues will be examined under microscope and studied using sophisticated chemical and biological tests. Immune cells from blood samples may also be examined. These studies will help better understand and diagnose the various eye diseases and to develop more attractive therapies.


Condition
Retinal Disease Corneal Disease Diabetic Retinopathy Uveitis Age-Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunopathology and Molecular Pathology of Ocular Diseases in Humans

Resource links provided by NLM:


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

Enrollment: 3797
Study Start Date: March 5, 1992
Estimated Study Completion Date: September 16, 2015
Detailed Description:
The purpose of this project is to diagnose and evaluate ocular and related tissues with various diseases such as conjunctival, corneal, uveal, vitreoretinal, scleral, optic nerve, and orbital disorders, ocular degenerative, inflammatory, metabolic or genetic diseases, and tumors. These will be studied using light microscopy, electron microscopy, confocal microscopy, immunohistochemistry, molecular pathology including microdissection and polymerase chain reaction and in situ hybridization, ELISA, as well as measuring the functions of cellular organelles, e.g., mitochondrial function. Lymphocytes in the peripheral blood, serum, as well as other involved biopsied tissues and ocular tissue will be compared and categorized by disease and normal. Cytokines, chemokines, growth factors, antibodies, and/or other released molecules in the blood, CSF, and ocular fluids will be also analyzed. We will compare the tissue morphology as well as immunological and biochemical indexes, e.g., cytokine/chemokine levels, growth factors, and antibodies between the diseases and normals. Elucidating the relationship between the infiltrating cells, ocular resident cells, and their products in various diseases will help us to make diagnoses, increase our understanding of human ocular disorders, and assist therapy.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Up to 5,000 subjects will be enrolled in the study at all sites combined. Subjects will be enrolled at NEI.

  1. Participants must be undergoing an eye procedure for clinical care of their condition which requires the removal of tissue specimens or have agreed pre-mortem to donate their eyes after death for research purposes.
  2. Participants must agree to the de-identified storage of their sample for potential use in future research projects.
  3. For conditions where blood is needed for analysis, participants must consent to having blood drawn for research evaluation, and be able to safely give a blood sample.
  4. Participants must be able to give informed consent for themselves and/or their minor children who wish to enroll.

EXCLUSION CRITERIA:

1. Participant is unwilling or unable to give informed consent.

  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: NCT00001310

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Principal Investigator: Robert B Nussenblatt, M.D. National Eye Institute (NEI)
  More Information

Publications:
Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00001310     History of Changes
Other Study ID Numbers: 920113
92-EI-0113
Study First Received: November 3, 1999
Last Updated: April 21, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Retinal Disease
Diabetic Retinopathy
Uveitis
Age-Related Macular Degeneration
Corneal Disease
Ocular Disease

Additional relevant MeSH terms:
Retinal Diseases
Macular Degeneration
Diabetic Retinopathy
Uveitis
Corneal Diseases
Eye Diseases
Retinal Degeneration
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on June 28, 2017