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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 2, 2008 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | June 2008 | ||||||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00708955 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation and Treatment of People With Eye Diseases | ||||||||
| Official Title ICMJE | Evaluation and Treatment Protocol for Potential Research Participants With Ocular Diseases | ||||||||
| 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. ... |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Other | ||||||||
| Condition ICMJE | Eye Diseases | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 5000 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Participants will be eligible if they:
EXCLUSION CRITERIA: Participants will not be eligible if they:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00708955 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 080169, 08-EI-0169 | ||||||||
| Study Sponsor ICMJE | National Eye Institute (NEI) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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