Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration (AMD)
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|ClinicalTrials.gov Identifier: NCT01337414|
Recruitment Status : Unknown
Verified April 2011 by Johns Hopkins University.
Recruitment status was: Recruiting
First Posted : April 18, 2011
Last Update Posted : April 18, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Age-related Macular Degeneration||Behavioral: VMS diary booklet Behavioral: Standard of Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tools to Optimize Patient Presentation After Onset of Exudative AMD (Using the VMS Interactive Education and Early Detection Multi-Test)|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2012|
|Experimental: VMS diary booklet||Behavioral: VMS diary booklet|
|Active Comparator: Usual Care (e.g. Amsler grid monitoring)||Behavioral: Standard of Care|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337414
|Contact: Gislin Dagnelie, PhDfirstname.lastname@example.org|
|Contact: Ava K Bittner, OD, PhDemail@example.com|
|United States, Maryland|
|Johns Hopkins University Wilmer Eye Institute||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Ellen Arnold 410-955-6782 firstname.lastname@example.org|
|Contact: Gislin Dagnelie, PhD 410-614-4822 email@example.com|
|Principal Investigator: Gislin Dagnelie, PhD|
|Sub-Investigator: Ava K Bittner, OD, PhD|