Protocol Details
Adaptive Optics Retinal Imaging
This study is currently recruiting participants.
Summary
Number | 15-EI-0020 |
Sponsoring Institute | National Eye Institute (NEI) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12 Years
Max Age: 120 Years |
Referral Letter Required | No |
Population Exclusion(s) | None |
Keywords | Eye Disease;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Eye Diseases;
Healthy Volunteers |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Eye Institute |
Background:
- By the time diseases of the retina are detected, serious damage has often already been done. Researchers want to find better ways of viewing the retina. One way called adaptive optics may help detect problems earlier.
Objectives:
- To study if adaptive optics can help find better ways to diagnose, treat, and manage retinal diseases.
Eligibility:
- People over age 12 with an eye disease.
- Healthy volunteers over age 12.
Design:
- Participants will be screened with medical history and eye exams. These may include dilating pupils and taking pictures of the eyes.
- Participants will have 1 or more study visits. They will have:
- Medical and eye history.
- Questions about their medications.
- Eye exam including pupil dilation.
- Adaptive optics imaging. After dilation, participants sit still while looking into an adaptive optics instrument. They look at specific places and images are taken of their retina.
- They may also have:
- More images.
- Perimetry. Participants look into a lens and press a button when they see a light.
- Color vision tests.
- Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be put on their forehead. They will look at flashing lights and try not to blink.
Eligibility
INCLUSION CRITERIA:
Participants will be eligible if they:
-Are 12 years of age or older.
-Have the ability to cooperate with an eye exam and adaptive optics imaging.
-Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children.
-Have an eye disease or are a healthy volunteer with a normal eye exam (no visually-significant eye findings on examination).
EXCLUSION CRITERIA:
Participants will not be eligible if:
-They have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity).
EXCLUSION CRITERIA FOR FLUORESCEIN AND/OR INDOCYANINE GREEN IMAGING
Partaicipants are not eligible for fluorescein and/or indocyanine green imaging if they:
-Are under 18 years of age.
-For participants who will undergo fluorescein imaging have a history of adverse reaction to fluorescein.
-For participants who will undergo indocyanine green imaging have a history of adverse reaction to indocyanine green dye, know or suspected allergies to iodine or shellfish.
Citations:
Hendrickson A, Drucker D. The development of parafoveal and mid-peripheral human retina. Behav Brain Res. 1992 Jul 31;49(1):21-31. Wing GL, Blanchard GC, Weiter JJ. The topography and age relationship of lipofuscin concentration in the retinal pigment epithelium. Invest Ophthalmol Vis Sci. 1978 Jul;17(7):601-7. Fotedar R, Wang JJ, Burlutsky G, Morgan IG, Rose K, Wong TY, Mitchell P. Distribution of axial length and ocular biometry measured using partial coherence laser interferometry (IOL Master) in an older white population. Ophthalmology. 2010 Mar;117(3):417-23. doi: 10.1016/j.ophtha.2009.07.028. Epub 2010 Jan 19.
Contacts:
Clinical Trials Number:
NCT02317328