Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration (AMD)



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:8/16/2018
Start Date:May 2010
End Date:December 2020

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Tools to Optimize Patient Presentation After Onset of Exudative AMD (Using the VMS Interactive Education and Early Detection Multi-Test)

Exudative age-related macular degeneration ("wet" AMD) continues to be a leading cause of
central vision loss in the US for those over fifty years of age, despite the availability of
several effective interventions to contain damaging neovascularization (new, abnormal blood
vessel growth). The effectiveness of treatments is challenged by patients' lack of ability to
recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi
tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling
patients to recognize the signs that they should consult their retina specialist for
treatment.

For optimal benefit, patients should be able to self-monitor their vision over time and
detect changes that may be indicative of an exudative event. To facilitate compliance these
observations should be part of a larger and more engaging program of AMD awareness and
self-monitoring. Among the principal shortcomings of the current "gold-standard" Amsler grid
are periodicity of the test pattern and lack of individual adjustment, and therefore the
reliability and accuracy of this test are less than optimal for the detection of exudative
retinal changes in AMD patients. In phase I of the current study, the investigatorsW
developed and evaluated several versions of improved grids, both on paper and on the
Internet. These patent-pending Visual and Memory Stimulating (VMS) grids proved at least
equivalent to the Amsler grid in facilitating a substantial degree of recall of prior
measurements, necessary for monitoring vision over time. Adjustment features were
incorporated in the on-line version to allow patients to customize their grid to their
particular visual field. In the phase II study the use of VMS grids will be supplemented by a
test booklet that contains educational materials and diary based survey questions in addition
to the printed VMS grids; the effectiveness of this booklet for self-monitoring will be
compared the standard of care (Amsler grid).

Goal of the study is to demonstrate that use of the test booklet leads to more rapid
identification of newly developing vision problems, earlier diagnosis and treatment of
incipient wet AMD that should result in fewer people losing their vision and less severe
losses of vision.


Inclusion Criteria:

- Subjects with a confirmed diagnosis of AREDS grade 3 or 4 AMD in at least one eye will
be recruited for components 1 and 2 of the study. The participants will include
healthy adults who are willing and able to complete the study tests. We will recruit
AMD patients across a wide range of races and ages, but due to the prevalence of AMD,
most of the patients will be Caucasian and over age 55. We will verify ocular
diagnosis and visual function status of all subjects through records and communication
provided by their retinal specialist.

Exclusion Criteria:

- Subjects with vision loss due to ocular pathology other than AMD or cataracts will be
excluded.

- Subjects with cataract extraction in the last 3 months or capsulotomy in the last 24
hours in either eye will also be excluded, as well as those who are unable to give
informed consent, non-English speaking or unable complete any other required study
procedure.
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