Evaluation and Treatment of People With Eye Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00708955
First received: July 2, 2008
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

This study will evaluate and provide standard treatments for people with various eye conditions. It will provide a resource for enrollment into new research protocols throughout the Eye Institute and will allow institute specialists the opportunity to maintain their expertise and gain additional knowledge of the course of various eye disorders. The information obtained will allow for the evaluation of standard treatments and may lead to ideas for future research.

People with diagnosed or undiagnosed eye disease and first-degree relatives of people with a genetic or developmental eye disease may be eligible for this study. Participants are evaluated and treated in the National Eye Institute. Blood or other tissue samples (e.g., urine, stool, hair, saliva or cheek swab) may be collected for future laboratory studies.

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Condition
Eye Diseases

Study Type: Observational
Official Title: Evaluation and Treatment Protocol for Potential Research Participants With Ocular Diseases

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Visual Acuity

Secondary Outcome Measures:
  • Other Visual or Ocular Function

Estimated Enrollment: 5000
Study Start Date: June 2008
Detailed Description:

The National Eye Institute (NEI) is conducting a study to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed ocular conditions.

Objectives: The primary objective of this protocol is to provide a reservoir of patients with multiple ocular diseases for enrollment into new research protocols throughout the NEI laboratories. Evaluating and treating participants will allow the NEI specialists to maintain their expertise and gain additional knowledge of the course of various eye disorders. The information obtained will allow for the evaluation of standard treatments of the studied eye diseases. This understanding may lead to ideas for future protocols. In some cases, blood or other biologic samples (including tear fluid, urine, saliva, hair, stool or a cheek swab) will be obtained for future laboratory studies.

Study Population: The number of participants to be enrolled has no logical upper limit, but will be set to 5,000 patients with ocular diseases and their unaffected first-degree relatives.

Design: This is an observational natural history study of multiple ocular diseases and their progression and physiology.

Outcome Measures: No formal outcomes will be measured; however the clinical assessments of enrolled participants can be used to measure the response to standard treatment. In addition, DNA samples obtained may be used to identify and verify causative mutations, which may help establish pathogenic mechanisms and genotype-phenotype correlations.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Participants will be eligible if they:

  • Have either a diagnosed or undiagnosed eye disease, OR are an unaffected first-degree relative of a participant with a genetic or developmental eye disease.
  • Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children.

EXCLUSION CRITERIA:

Participants will not be eligible if they:

  • Are unable or unwilling to give informed consent.
  • Are unwilling or unable to be followed as clinically indicated.
  • Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment.
  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: NCT00708955

Contacts
Contact: Wendy Holland, R.N. (301) 435-1831 aholland@nei.nih.gov
Contact: Rachel J Bishop, M.D. (301) 402-3771 bishopra@nei.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: Rachel J Bishop, M.D. National Eye Institute (NEI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00708955     History of Changes
Other Study ID Numbers: 080169, 08-EI-0169
Study First Received: July 2, 2008
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Evaluation and Treatment
Eye Diseases

Additional relevant MeSH terms:
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014