Screening for Research Participants
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/6/2019 |
| Start Date: | April 7, 2008 |
| Contact: | Awilda (Wendy) Holland, R.N. |
| Email: | aholland@nei.nih.gov |
| Phone: | (301) 435-1831 |
Screening Study for the Evaluation and Diagnosis of Potential Research Participants
This study will allow National Eye Institute (NEI) doctors the opportunity to examine people
with eye disease, whether the diagnosis is known or not, to determine if they are eligible
for other NEI research studies. No treatment is offered in this study.
People of all ages with various eye conditions, including genetic conditions, eye movement
disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be
eligible for this study.
Participants undergo various tests and procedures to diagnose or evaluate their eye disease.
The procedures may include the following:
- Personal and family medical history
- Physical examination and blood tests, including genetic testing.
- Eye examination with dilation to measure visual acuity and eye pressure and to examine
the front and back parts of the eye.
- Questionnaire about vision and daily activities.
- Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is
collected by swabbing the surface of the eye or by surgically removing a small sample of
the surface of the eye or tear gland.
- Electroretinogram to examine retinal function: The subject sits in the dark with his or
her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is
numbed, and contact lenses that can sense signals from the retina are placed on the
eyes. The subject then watches flashing lights.
- Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into
a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A
camera takes pictures of the dye as it flows through the blood vessels.
- Optical coherence tomography to measure retinal thickness: A machine used to examine the
eyes produces cross-sectional pictures of the retina.
- Microperimetry to test how sensitive different parts of the retina are to changing
levels of light. The subject sits in front of a computer and presses a button when he or
she sees a light on the screen.
- Oculography to record eye movements: Eye movements are measured by contact lenses or
goggles that the subject wears while watching a series of spots on a computer screen.
with eye disease, whether the diagnosis is known or not, to determine if they are eligible
for other NEI research studies. No treatment is offered in this study.
People of all ages with various eye conditions, including genetic conditions, eye movement
disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be
eligible for this study.
Participants undergo various tests and procedures to diagnose or evaluate their eye disease.
The procedures may include the following:
- Personal and family medical history
- Physical examination and blood tests, including genetic testing.
- Eye examination with dilation to measure visual acuity and eye pressure and to examine
the front and back parts of the eye.
- Questionnaire about vision and daily activities.
- Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is
collected by swabbing the surface of the eye or by surgically removing a small sample of
the surface of the eye or tear gland.
- Electroretinogram to examine retinal function: The subject sits in the dark with his or
her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is
numbed, and contact lenses that can sense signals from the retina are placed on the
eyes. The subject then watches flashing lights.
- Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into
a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A
camera takes pictures of the dye as it flows through the blood vessels.
- Optical coherence tomography to measure retinal thickness: A machine used to examine the
eyes produces cross-sectional pictures of the retina.
- Microperimetry to test how sensitive different parts of the retina are to changing
levels of light. The subject sits in front of a computer and presses a button when he or
she sees a light on the screen.
- Oculography to record eye movements: Eye movements are measured by contact lenses or
goggles that the subject wears while watching a series of spots on a computer screen.
This protocol is designed for the screening of potential research participants with or
without a defined diagnosis. This protocol will serve as a point of entry for individuals who
may be eligible and wish to participate in the National Eye Institute (NEI) clinical research
studies.
Participants referred or self-referred for a second opinion will be also screened and
evaluated during the screening process to determine whether they are suitable participants
for any of the ongoing NEI research studies. The screening process will include past and
current medical history, a physical examination, routine diagnostic procedures and required
testing as needed to help determine a participant s eligibility for research participation
and diagnosis. Other routine diagnostic procedures and tests may also be done to help
determine a participant s eligibility. Once the screening process is complete, participants
will be informed of their options to participate in one or more of the NEI s current clinical
research protocols. If no suitable research protocol for their participation is identified,
recommendations for other treatment options may be given to the individual, their primary
provider or referring physician.
This protocol s secondary aim is to collect and store human biospecimens and health
information for basic science laboratory research. Basic science research may be both
hypothesis generating and/or hypothesis testing. Biospecimen samples such as blood, body
fluid (e.g., urine), genomic, and tissue (e.g., skin or hair) may be collected from affected
or unaffected adult participants as well as affected pediatric participants; biospecimen
samples can be collected at the time of screening or anytime thereafter. These samples may be
used for basic science laboratory research or stored and used in future research studies.
Through such studies, the investigators hope to find possible new ways to detect, treat and
possibly even prevent or cure ophthalmological diseases. Biospecimen sample collection will
be voluntary for all participants, and participants will be consented using the Screening and
Biospecimen Collection consent prior to their participation in this arm of the study.
without a defined diagnosis. This protocol will serve as a point of entry for individuals who
may be eligible and wish to participate in the National Eye Institute (NEI) clinical research
studies.
Participants referred or self-referred for a second opinion will be also screened and
evaluated during the screening process to determine whether they are suitable participants
for any of the ongoing NEI research studies. The screening process will include past and
current medical history, a physical examination, routine diagnostic procedures and required
testing as needed to help determine a participant s eligibility for research participation
and diagnosis. Other routine diagnostic procedures and tests may also be done to help
determine a participant s eligibility. Once the screening process is complete, participants
will be informed of their options to participate in one or more of the NEI s current clinical
research protocols. If no suitable research protocol for their participation is identified,
recommendations for other treatment options may be given to the individual, their primary
provider or referring physician.
This protocol s secondary aim is to collect and store human biospecimens and health
information for basic science laboratory research. Basic science research may be both
hypothesis generating and/or hypothesis testing. Biospecimen samples such as blood, body
fluid (e.g., urine), genomic, and tissue (e.g., skin or hair) may be collected from affected
or unaffected adult participants as well as affected pediatric participants; biospecimen
samples can be collected at the time of screening or anytime thereafter. These samples may be
used for basic science laboratory research or stored and used in future research studies.
Through such studies, the investigators hope to find possible new ways to detect, treat and
possibly even prevent or cure ophthalmological diseases. Biospecimen sample collection will
be voluntary for all participants, and participants will be consented using the Screening and
Biospecimen Collection consent prior to their participation in this arm of the study.
- INCLUSION CRITERIA:
Participants will be able to enroll if they:
- Have a diagnosed ocular disease/disorder; OR
- Potentially have an unusual, interesting, or unknown ocular condition that requires
the establishment of a diagnosis; OR
- Potentially participate as a disease-free control participant in an NEI clinical
research study; OR
- Are an unaffected first-degree relative of a participant with either a diagnosed or
undiagnosed ocular disorder; AND
- Have the ability to understand and sign an informed consent OR if they are minor
children have a legal parent/guardian with the ability to do the same.
- Adults with impaired capacity to consent must have a legally authorized representative
that is able to provide informed consent.
EXCLUSION CRITERIA:
Participants will be unable to enroll if they:
-Are unwilling or unable to cooperate with the study procedures.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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