This study is NOT currently recruiting participants.
Number
14-EI-0171
Sponsoring Institute
National Eye Institute (NEI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 10 Years Max Age: 100 Years
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Retinal Images; Retinal Pigment Epithelium; Natural History
Recruitment Keyword(s)
Condition(s)
Macular Degeneration; Age-Related Macular Degeneration
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Eye Institute
- Maculopathies are eye conditions that affect the center of the retina. Retina health depends on the retinal pigment epithelium (RPE), a layer behind the retina. A new test may measure the health of the central retina and RPE.
Objective:
- To use the focal electro-oculogram (EOG) test to understand how the central retina and RPE are affected in maculopathies.
Eligibility:
- People at least 10 years old with a maculopathy.
- Healthy volunteers with visual acuity of 20/20 or better in at least one eye.
Design:
- Participants will be screened with medical and eye history and an eye exam. Pictures will be taken of the eyes.
- Their eyes may be dilated.
- They may have a field test. They will look into a lens and press a button when they see a light. First, they may sit in the dark for 40 minutes.
- Participants will have 1-7 visits over 18 months.
- Their vision will be tested and eye pressure measured.
- Their pupils will be dilated with eye drops and researchers may take pictures of the retina and the inside of the eye, and measure the thickness of the retina.
- Participants will have an electro-oculogram. They will look at a 2 LED lights and follow them back and forth for 10 seconds once per minute. Participants will be in darkness for 15 minutes and in light for 20 minutes. One skin electrode will be placed on the nose and one next to the eye.
- Participants with maculopathy will also have:
- Field test.
- Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be taped to the forehead. Participants will watch flashing lights and try not to blink. First, they may sit in the dark for 40 minutes.
--Back to Top--
INCLUSION CRITERIA: 1) Participant must be 10 years of age or older. 2) Participant (or legal guardian) must understand and sign the protocol s informed consent document. 3) Participant must be able to cooperate with the testing required for this study. 4) For Participants with macular disease only: (a) Participant must have macular disease, defined as evidence of loss of centrally mediated retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging. (b) Participant must have a measurable visual acuity. 5) For Healthy Volunteers only: (a) Participant must have visual acuity of 20/20 or better in at least one eye. EXCLUSION CRITERIA: 1) Participant with pre-retinal media opacities that would prevent focal light presentation.
1) Participant must be 10 years of age or older.
2) Participant (or legal guardian) must understand and sign the protocol s informed consent document.
3) Participant must be able to cooperate with the testing required for this study.
4) For Participants with macular disease only:
(a) Participant must have macular disease, defined as evidence of loss of centrally mediated retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging.
(b) Participant must have a measurable visual acuity.
5) For Healthy Volunteers only:
(a) Participant must have visual acuity of 20/20 or better in at least one eye.
EXCLUSION CRITERIA:
1) Participant with pre-retinal media opacities that would prevent focal light presentation.
Principal Investigator
Referral Contact
For more information: