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Sponsors and Collaborators: |
Schepens Eye Research Institute Chadwick Optical Inc. |
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Information provided by: | Schepens Eye Research Institute |
ClinicalTrials.gov Identifier: | NCT00494676 |
The purpose of this study is to evaluate the functional utility for general mobility (walking) of new high power permanent peripheral prism glasses, which provide visual field expansion device for patients with homonymous hemianopia (the complete loss of half the field of vision on the same side in both eyes).
Condition | Intervention |
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Homonymous Hemianopia |
Device: High power (57 prism diopter) peripheral prism glasses |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment |
Official Title: | Community-Based Multi-Center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia |
Estimated Enrollment: | 60 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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All
There are no "arms" as such for this trial. It is a cross-over design; all participants receive both the real prism glasses and the sham prism glasses
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Device: High power (57 prism diopter) peripheral prism glasses
All patients will wear two pairs of prism glasses in a cross-over design: the high power peripheral prism glasses and sham peripheral prism glasses. Each pair of prism glasses will be worn for four weeks
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Patients with hemianopic field loss are unaware of objects in their blind (non-seeing) hemi-field and often experience difficulties with mobility and navigation, such as walking into obstacles on the side of the field loss. In 2000, Peli (2000) described a new peripheral-prism design of prismatic correction for hemianopia, which addresses many of the inadequacies of existing designs of hemianopic visual aids, and produces true field expansion (i.e. the simultaneously seen field is larger with the device than without). In collaboration with the Schepens Eye Research Institute (Boston, MA), Chadwick Optical Inc (White River Junction, VT) has developed a permanent form of Fresnel prism segments, which are made from an acrylic material and can be embedded in a plastic spectacle lens. These permanent prisms offer better cosmesis, optical quality and durability than the temporary 40 prism-diopter press-on Fresnel prism segments used in previous evaluations of the peripheral prism system.
In this study we will evaluate new high-power (57 prism diopter) permanent peripheral prism glasses. Two designs will be evaluated - the "oblique" design and the "horizontal" design. Each design provides expansion in a different area of the visual field. The functional utility of the two designs for general mobility will be assessed.
Each participant will wear both designs of glasses in a cross-over fashion; one pair will contain real prisms and the other pair will contain sham, low power prisms, that provide little field expansion. Real prisms and sham prisms will appear similar. Participants will have either the "oblique" or the "horizontal" design in their real prism glasses and the other design in their sham prism glasses. Prism glasses will be fitted by Low Vision Practitioners at community-based Vision Rehabilitation Clinics.
After wearing the first pair of glasses for 4 weeks, participants will return for an in-office follow up visit, at which a questionnaire will be administered to record their experiences of wearing the glasses. The second pair of prism glasses will then be fitted. Another questionnaire will be administered 4 weeks later to record the experiences of wearing the second set of glasses.
At the end of the period of wearing the second pair of prism glasses, a clinical decision will be made as to whether the participant should continue to use the prism glasses (e.g. if a participant finds the prism glasses helpful for obstacle avoidance when walking). For participants who continue with the prism glasses, a final telephone follow-up interview will be conducted after about 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alex R Bowers, PhD | 617-912-2512 | alex.bowers@schepens.harvard.edu |
United States, Alabama | |
UAB Center for Low Vision Rehabilitation | Recruiting |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Vista Center for the Blind and Visually Impaired | Completed |
Palo Alto, California, United States, 94306 | |
United States, Florida | |
Visual Health@Jupiter Eye Center | Recruiting |
Jupiter, Florida, United States, 33458 | |
United States, Georgia | |
Emory Optical Low Vision | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Illinois Eye Institute | Recruiting |
Chicago, Illinois, United States, 60616 | |
United States, Indiana | |
Indiana University School of Optometry, Low Vision Rehabilitation and Primary Care Services | Recruiting |
Bloomington, Indiana, United States, 47404 | |
United States, Kansas | |
University of Kansas Medical Center | Recruiting |
Prairie Village, Kansas, United States, 66208 | |
United States, Massachusetts | |
Vision Care Specialists, P.C. | Recruiting |
Southborough, Massachusetts, United States, 01772 | |
Schepens Eye Research Institute | Recruiting |
Boston, Massachusetts, United States, 02114 | |
United States, North Carolina | |
Seven Lakes Eye Care | Recruiting |
West End, North Carolina, United States, 27376 | |
Academy Eye Associates | Recruiting |
Durham, North Carolina, United States, 27707 | |
United States, Ohio | |
United Disability Services / Low Vision | Withdrawn |
Akron, Ohio, United States, 44311 | |
United States, Oklahoma | |
NSU Oklahoma College of Optometry, | Recruiting |
Tahlequah, Oklahoma, United States, 74464 | |
United Kingdom | |
Manchester Royal Eye Hospital | Recruiting |
Manchester, United Kingdom, M60 1QD |
Principal Investigator: | Alex R Bowers, PhD | Schepens Eye Research Institute |
Principal Investigator: | Karen Keeney, MSBA | Chadwick Optical Inc. |
Responsible Party: | Schepens Eye Research Institute ( Alex Bowers ) |
Study ID Numbers: | 2006-016, R44 - EY014723 |
Study First Received: | June 28, 2007 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00494676 |
Health Authority: | United States: Institutional Review Board |
Hemianopia Mobility Rehabilitation Low vision |
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