Evaluation and Treatment of People With Eye Diseases

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00708955
Collaborator
(none)
2,164
1
108.6
19.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2164 participants
    Time Perspective:
    Other
    Official Title:
    Evaluation and Treatment Protocol for Potential Research Participants With Ocular Diseases
    Study Start Date :
    Jun 25, 2008
    Study Completion Date :
    Jul 12, 2017

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      • 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

      Locations

      Site City State Country Postal Code
      1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Eye Institute (NEI)

      Investigators

      • Principal Investigator: Rachel J Bishop, M.D., National Eye Institute (NEI)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      National Eye Institute (NEI)
      ClinicalTrials.gov Identifier:
      NCT00708955
      Other Study ID Numbers:
      • 080169
      • 08-EI-0169
      First Posted:
      Jul 3, 2008
      Last Update Posted:
      Dec 16, 2019
      Last Verified:
      Jul 12, 2017
      Keywords provided by National Eye Institute (NEI)
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Dec 16, 2019