NCT00001310

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,833

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1992

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 1992

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
15.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2015

Completed
Last Updated

December 9, 2019

Status Verified

September 16, 2015

First QC Date

November 3, 1999

Last Update Submit

December 6, 2019

Conditions

Retinal DiseaseCorneal DiseaseDiabetic RetinopathyUveitisAge-Related Macular Degeneration

Keywords

Retinal DiseaseDiabetic RetinopathyUveitisAge-Related Macular DegenerationCorneal DiseaseOcular Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. Participant is unwilling or unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Chan CC. Molecular pathology of primary intraocular lymphoma. Trans Am Ophthalmol Soc. 2003;101:275-92.

    PMID: 14971583BACKGROUND

  • Ding X, Patel M, Chan CC. Molecular pathology of age-related macular degeneration. Prog Retin Eye Res. 2009 Jan;28(1):1-18. doi: 10.1016/j.preteyeres.2008.10.001. Epub 2008 Nov 6.

    PMID: 19026761BACKGROUND

  • Chan CC, Li Q. Immunopathology of uveitis. Br J Ophthalmol. 1998 Jan;82(1):91-6. doi: 10.1136/bjo.82.1.91. No abstract available.

    PMID: 9536890BACKGROUND

MeSH Terms

Conditions

Retinal DiseasesCorneal DiseasesDiabetic RetinopathyUveitisMacular Degeneration

Condition Hierarchy (Ancestors)

Eye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesUveal DiseasesRetinal Degeneration

Study Officials

  • Robert B Nussenblatt, M.D.

    National Eye Institute (NEI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 5, 1992

Study Completion

September 16, 2015

Last Updated

December 9, 2019

Record last verified: 2015-09-16

Locations

US(1)