Screening for Research Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00655096
Recruitment Status : Recruiting
First Posted : April 9, 2008
Last Update Posted : December 5, 2018
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 either a diagnosed or undiagnosed ocular condition. Participants without any evidence of an ocular condition can also be screened using this protocol. This protocol serves 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 will be carefully evaluated during the screening process to determine whether they are suitable candidates for inclusion in any of the ongoing NEI research studies. The screening process will include past and current medical history and, as appropriate, a physical examination. Other routine diagnostic procedures and tests may also be conducted in order to help determine a participant s eligibility. These tests and procedures have minimal risks associated with them. Once the screening process is complete and eligibility is determined, 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.

Study Type : Observational
Estimated Enrollment : 10000 participants
Time Perspective: Retrospective
Official Title: Screening Study for the Evaluation and Diagnosis of Potential Research Participants
Study Start Date : April 7, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Primary Outcome Measures :
  1. Since this is a screening protocol, there are no formal outcomes to be measured.

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.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.


Participants will be unable to enroll if they:

-Are unwilling or unable to cooperate with the study procedures.

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 identifier (NCT number): NCT00655096

Contact: Awilda (Wendy) Holland, R.N. (301) 435-1831
Contact: Awilda V Holland (301) 435-7831

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   
Sponsors and Collaborators
National Eye Institute (NEI)
Principal Investigator: Awilda V Holland National Eye Institute (NEI)

Additional Information:
Responsible Party: National Eye Institute (NEI) Identifier: NCT00655096     History of Changes
Other Study ID Numbers: 080102
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: November 15, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Screening Protocol
Eye Diseases

Additional relevant MeSH terms:
Eye Diseases