Screening for Research Participants

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00655096
First received: April 8, 2008
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

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
Eye Diseases

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Screening Study for the Evaluation and Diagnosis of Potential Research Participants

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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

Estimated Enrollment: 5000
Study Start Date: April 2008
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

EXCLUSION CRITERIA:

Participants will be unable to enroll if they:

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655096

Contacts
Contact: Wendy Holland, R.N. (301) 435-1831 aholland@nei.nih.gov
Contact: Awilda V Holland (301) 435-7831 aholland@nei.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Awilda V Holland National Eye Institute (NEI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00655096     History of Changes
Other Study ID Numbers: 080102, 08-EI-0102
Study First Received: April 8, 2008
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Eye Diseases

ClinicalTrials.gov processed this record on August 19, 2014