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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | July 3, 2008 |
| Start Date ICMJE | March 1998 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE |
Level of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). |
| Change History | Complete list of historical versions of study NCT00001733 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE |
The Hamilton Psychiatric Rating Scale for Anxiety (HAMA) and the Clinical Global Impression (CGI) severity scores. |
| Descriptive Information | |
| Brief Title ICMJE | Screening for Studies on Retinovascular Diseases |
| Official Title ICMJE | Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Retinovascular Diseases |
| Brief Summary | This screening protocol is designed to help recruit patients for National Eye Institute (NEI) studies of the retina, such as diabetic retinopathy and macular degeneration. Patients must meet the specific criteria of a research study, and this protocol serves as a first step for admitting patients to a retinal disease study. Candidates will undergo a medical history and comprehensive eye examination. The eye examination includes dilation of the pupils to fully examine the retina. In some studies, photographs of the eye are required. This is done using fluorescein angiography. In this procedure, a dye called sodium fluorescein is injected into the blood stream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. Other diagnostic procedures may include physical examination, questionnaires, routine laboratory tests and other standard or specialized tests, as needed. When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol. |
| Detailed Description | This protocol is designed for the screening of patients with presumed retinovascular diseases. It serves as a first step for individuals who may be eligible and wish to participate in National Eye Institute clinical research studies of retinovascular diseases. Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the National Eye Institute ongoing studies. The screening evaluation will include past and current medical histories and an appropriate physical examination, namely a comprehensive eye exam. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risk and will be described in more detail in section III: "Study Procedures." Once the screening process is completed and their eligibility is assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| 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 | Completed |
| Enrollment ICMJE | 2000 |
| Completion Date | July 2008 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study. All studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001733 |
| Responsible Party | |
| Study ID Numbers ICMJE | 980076, 98-EI-0076 |
| Study Sponsor ICMJE | National Eye Institute (NEI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | July 2008 |
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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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