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HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device

NCT01103505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1520

Last updated 2019-07-30

Study results available
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Summary

The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 improves detection of progression to choroidal neovascularization (CNV) when compared with standard care.

Conditions

  • Age Related Macular Degeneration

Interventions

DIAGNOSTIC_TEST

ForeseeHome AMD Monitoring Device

Earlier detection of progression from intermediate dry age-related macular degeneration to CNV between routine eye exams through home diagnostic testing with the ForeseeHome AMD Monitoring device

Sponsors & Collaborators

  • Notal Vision Ltd.

    lead INDUSTRY

Principal Investigators

  • Emily Chew, MD · National Eye Institute (NEI)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-10-31
Completion
2013-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103505 on ClinicalTrials.gov