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Evaluation and Treatment of People With Eye Diseases
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), April 2009
First Received: July 2, 2008   Last Updated: August 24, 2009   History of Changes
Sponsor: National Eye Institute (NEI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00708955
  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:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

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

Estimated Enrollment: 5000
Study Start Date: June 2008
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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 resource of patients 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708955

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 080169, 08-EI-0169
Study First Received: July 2, 2008
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00708955     History of Changes
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 November 30, 2009



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