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Home Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the Foresee Home Device
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
11-EI-0124 |
Sponsoring Institute |
National Eye Institute (NEI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Age-Related Macular Degeneration (AMD); |
Recruitment Keyword(s) |
Age-Related Macular Degeneration; |
Condition(s) |
Age-Related Macular Degeneration |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Device: ForeseeHome AMD Mointor |
Supporting Site |
|
- In the wet form of age-related macular degeneration (AMD), new blood vessels grow and cause fluid leaks into the retina, which leads to loss of vision. Some studies suggest that if the development of new blood vessels (choroidal neovascularization, or CNV) is detected early, treatment could be started sooner, which may help prevent visual loss. One possible method of early detection is the ForeseeHome device, which is part of a program designed to allow individuals to monitor their eyes for vision changes at home. Researchers are interested in comparing eye disease progression in people using the ForeseeHome device with those not using the device.
Objectives:
- To determine if home monitoring of age-related macular degeneration using the ForeseeHome device can help detect progression of disease earlier than standard care.
Eligibility:
- Individuals at least 55 years of age who are participating in the AREDS2 study, are at risk for choroidal neovascularization in at least one eye, and are able to use the ForeseeHome device correctly.
Design:
- Participants will be screened with a physical examination, medical history, and eye examinations. Participants will also be introduced to the device in order to determine if they will be able to use it for the duration of the study.
- Half of the study participants will receive the ForeseeHome device; the other half will have standard of care monitoring. Participants will be asked only to monitor the eye(s) that are at risk for progression to wet AMD.
- Participants assigned to the device monitoring group will receive the ForeseeHome device, a personal monitor that has a head unit with a viewer and internal screen, and a modem connected to a telephone cord. This cord must be attached to a land telephone line so that it can send data to the sponsor. Set-up instructions will be included with the device.
- Participants will use the ForeseeHome device daily by looking at a screen and identifying certain patterns presented on the screen. The test takes about 4 minutes for each eye at risk. Test results will be transmitted by the modem to the sponsor, and the results will be reviewed by trained personnel. If the testing suggests a change in eye condition, participants and their AREDS2 clinic site will be notified by telephone and asked to schedule an appointment for an examination within 3 days of the call.
- Participants in the standard care group should continue to have regular clinic visits and the required AREDS2 study visits, and will monitor eye symptoms using the instructions provided by the eye doctor for identifying possible CNV. Participants should contact the AREDS2 clinic promptly and come to the clinic within 3 days of any changes in vision.
- The ForeseeHome device will be returned (1) after progression to CNV of the eye at risk, (2) at the end of the study, or (3) if use of the device produces unreliable results such that monitoring with the device becomes unreliable.
Eligibility
INCLUSION CRITERIA:
-Male or female Age-Related Eye Disease 2 (AREDS2) participant 55 years of age or older who is actively being followed in AREDS2 and is expected to continue until the end of AREDS2.
-Participant must be English speaking and understand and sign the protocol's informed consent document.
-Participant does not have advanced AMD (neovascular AMD or central geographic atrophy) in at least 1 eye. The eye(s) that does not have advanced AMD must have at least intermediate AMD and will be the study eye(s).
-Participant must be able to successfully demonstrate their ability to comprehend instructions and use of the ForeseeHome device (a ForeseeHome device will be available at the clinic for the participant to demonstrate their ability).
-Participant must have a working phone land line in the participant's main residence.
-Participant's address to which the ForeseeHome device will be sent, if randomized to the device monitoring arm, must be located in the U.S.A.
-Study eye(s) must have best corrected visual acuity 20/60 or better (at least 54 letters).
-Ocular media sufficient to allow adequate quality fundus photography.
-Participant must be willing to have name and contact information provided to Notal Vision.
-Participant must consent to be examined by the study ophthalmologist when changes in symptoms are detected by the home-device or by standard of care or when unreliable test results occur during the usage period.
-If randomized to the device monitoring arm, participant must agree to take the device with them if staying somewhere else other than their primary residence for seven days or more.
-Participant has some previous experience using equipment with similar user interfaces, e.g. pointer mouse devices on a personal computer.
EXCLUSION CRITERIA:
-Participant has evidence of macular or retinal disorders other than AMD in the study eye(s).
-Participant has known adverse reaction to fluorescein dye or refuses further fluorescein angiograms.
-Participant's eye is receiving (or is expected to receive) an eye examination on a continuing basis by an eye care professional more frequently than every four months.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Wai T. Wong, M.D. National Eye Institute (NEI) National Institutes of Health Building 7 Room 238 7 Center Drive Bethesda, Maryland 20892 (301) 496-7821 wongw@mail.nih.gov |
Katherine H. Shimel, R.N. National Eye Institute (NEI) National Institutes of Health Building 10 Room 10S215 10 Center Drive Bethesda, Maryland 20892 (301) 402-2863 shimelk@nei.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT01314430
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