Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT01334294
Eligibility Criteria:
Inclusion Criteria:
1. Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study
2. Last diagnosis was, and current diagnosis is, no CNV activity in SE eye
3. Current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks.
4. Visual acuity of 20/80 or better in SE
5. Are capable and agree to sign a consent form and participate in the study
6. Age \> 55 year of age
7. Are able to use a standard computer mouse correctly and without assistance
8. Have a working telephone landline at the main residence (cellular communication maybe available for the study, and then eliminate this requirement)
9. Clear view of the macular area on fundus photography
10. Are willing to give their name and contact information to Notal Vision, supplier of the device, so that the company can provide direct services if needed (e.g., assist in using the home device, report the frequency of usage, coordinate replacement of devices in case of a technical problems, etc.)
11. Agree to be examined by an ophthalmologist if SE shows symptoms of changes during the study
12. Have a US address and do not plan on traveling abroad during the study period
13. Fluent in English
14. Perform a reliable ForeseeHome test during the enrollment visit
Exclusion Criteria:
1. Evidence of macular disease other than AMD or glaucoma in SE
2. Presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy
3. Any non-macular related ocular surgery performed within 3 months prior to study entry in SE
4. Participant are not enrolled in another stuy that could affect the interval between clinical examinations, or the frequency of use of the ForeseeHome device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT01334294
Study Brief:
Protocol Section:
NCT01334294