Tissue Studies of Human Eye Diseases

Sponsor

National Eye Institute (NEI) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00001310

Collaborator

(none)

3,833

Enrollment

Location

282.4

Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Retinal Disease Corneal Disease Diabetic Retinopathy Uveitis Age-Related Macular Degeneration

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.

Study Design

Study Type:

Observational

Actual Enrollment :

3833 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Immunopathology and Molecular Pathology of Ocular Diseases in Humans

Study Start Date :

Mar 5, 1992

Study Completion Date :

Sep 16, 2015

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

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

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.
Participants must agree to the de-identified storage of their sample for potential use in future research projects.
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.
Participants must be able to give informed consent for themselves and/or their minor children who wish to enroll.