Screening for NEI Clinical Studies
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Ocular, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 1998 |
| End Date: | October 2008 |
Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Ocular Inflammatory or Immunologic Diseases
This screening protocol is designed to facilitate patient recruitment to National Eye
Institute (NEI) clinical research studies. Patients must meet specific requirements of a
research study; this protocol serves as a first step for admitting patients to an
appropriate program.
Candidates may have a diagnosed or undiagnosed eye condition. They will be screened with a
medical history, physical examination, eye examination and blood test. Other screening
procedures may include routine laboratory tests, non-invasive imaging, and questionnaires.
The eye examination includes measurement of eye pressure and dilation of the pupils to fully
examine the lens, vitreous and retina. Specialized eye tests will be done only if needed to
determine eligibility for a specific study. When the screening is completed, patients will
be informed of their options to participate in a study. Patients who are found ineligible
for a current study will be informed of alternative treatments or options. No treatment is
offered under this protocol.
Institute (NEI) clinical research studies. Patients must meet specific requirements of a
research study; this protocol serves as a first step for admitting patients to an
appropriate program.
Candidates may have a diagnosed or undiagnosed eye condition. They will be screened with a
medical history, physical examination, eye examination and blood test. Other screening
procedures may include routine laboratory tests, non-invasive imaging, and questionnaires.
The eye examination includes measurement of eye pressure and dilation of the pupils to fully
examine the lens, vitreous and retina. Specialized eye tests will be done only if needed to
determine eligibility for a specific study. When the screening is completed, patients will
be informed of their options to participate in a study. Patients who are found ineligible
for a current study will be informed of alternative treatments or options. No treatment is
offered under this protocol.
This protocol is designed for the screening of patients with either diagnosed or undiagnosed
conditions, and serves as a first step for individuals who may be eligible, and wish to
participate in NEI- National Eye Institute clinical research studies.
Each individual will be thoroughly evaluated during the screening process to determine if
they are suitable candidates for inclusion in any of the NEI ongoing studies. The screening
evaluation will include past and current medical histories, and an appropriate physical
examination. 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.
conditions, and serves as a first step for individuals who may be eligible, and wish to
participate in NEI- National Eye Institute clinical research studies.
Each individual will be thoroughly evaluated during the screening process to determine if
they are suitable candidates for inclusion in any of the NEI ongoing studies. The screening
evaluation will include past and current medical histories, and an appropriate physical
examination. 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.
- Participants will be able to enroll if they:
1. Have a diagnosed ocular inflammatory eye disease; OR
2. Have an unusual, interesting or unknown ocular condition that requires the
establishment of a diagnosis; AND
3. Have the ability to understand and sign an informed consent OR have a legal
parent/guardian with the ability to do the same.
2.2 Exclusion Criteria
Participants will be unable to enroll if they:
1. Have no ocular medical conditions; OR
2. Are unwilling or unable to cooperate with the procedures.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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