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Screening for Research Participants

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ClinicalTrials.gov Identifier: NCT00655096
Recruitment Status : Recruiting
First Posted : April 9, 2008
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Brief Summary:

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.

Condition or disease
Eye Diseases

Detailed Description:

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.

Patients who are referred or self-referred will be 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 may include past and current medical history, a physical examination, diagnostic procedures, and required testing used to establish a patient s diagnosis and determine his/her potential eligibility for research participation. Once the screening process is complete, patients will be informed of their options to participate in one or more of the NEI's current clinical research protocols or natural history studies. If no appropriate research protocol is

available for their participation, the patient may receive potential treatment recommendations, which will be shared with the patient s primary provider and referring physician.

This protocol's secondary aim is to collect and store human biospecimens and health information for basic science laboratory research and to generate and test hypotheses. Through such studies, research investigators hope to find possible new ways to detect, treat, and even prevent or cure ophthalmological diseases. Genetic and genomic testing, and biospecimen samples such as blood, body fluid (e.g., urine), and tissue (e.g., skin) may be collected from affected or unaffected adult participants. Biospecimen samples can be obtained at the time of screening or any time after screening. These samples, combined with other clinical data, may be used for basic science laboratory research or stored and used in future research studies. Biospecimen sample collection is voluntary for all participants.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Screening Protocol for the Evaluation and Diagnosis of Potential Research Participants
Actual Study Start Date : August 20, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Group/Cohort
Affected participants
Adults and children with either diagnosed or undiagnosed ocular conditions.
Disease free control
Adults and children without any ocular disorders.
Unaffected relative
Unaffected first degree relative of a genetic ocular disease participant.



Primary Outcome Measures :
  1. ascertain eligibility [ Time Frame: At screening ]
    Determine eligibility for additional NEI protocols.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants can be self-referred or be referrals from medical practitioners, clinics, hospitals, or medical institutions.
Criteria
  • 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 (LAR) who 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.
  • Female participants of childbearing potential who are pregnant are not eligible for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655096


Contacts
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Contact: Awilda (Wendy) Holland, R.N. (301) 435-1831 aholland@nei.nih.gov
Contact: Awilda V Holland, R.N. (301) 435-1831 aholland@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Awilda V Holland, R.N. National Eye Institute (NEI)
Additional Information:
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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00655096    
Other Study ID Numbers: 080102
08-EI-0102
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 4, 2021
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Eye
Photograph
Retina
Additional relevant MeSH terms:
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Eye Diseases