Clinical Trial of Peripheral Prism Glasses for Hemianopia
Community-based Multi-center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia
2 other identifiers
interventional
73
2 countries
13
Brief Summary
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). The efficacy of real peripheral prism glasses will be assessed relative to sham peripheral prism glasses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
July 2, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
September 13, 2013
CompletedApril 4, 2017
April 1, 2017
1.8 years
June 28, 2007
July 7, 2013
April 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Proportion Saying "Yes" to Real Prism Glasses
At the end of each crossover period, participants were asked a yes/no question: "If the study were to end today, would you want to continue with these prism glasses (i.e. the prism glasses worn in that period)?" The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants saying "yes" to real prism glasses and the proportion saying "yes" to sham prism glasses.
Evaluated after 4 weeks of wearing each type of prism glasses
Secondary Outcomes (3)
Mobility Change Score (All Participants Who Completed Crossover)
Evaluated after 4 weeks of wearing each type of prism glasses
Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)
Evaluated after 4 weeks of wearing each type of prism glasses
Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)
Evaluated after 4 weeks of wearing each type of prism glasses
Study Arms (2)
Real prism glasses first, then sham
EXPERIMENTALParticipants in this arm will receive high power (57 prism diopter) peripheral prism glasses in the first period of the crossover and low power sham peripheral prism glasses in the second period
Sham prism glasses first, then real
EXPERIMENTALParticipants in this arm will receive low power sham peripheral prism glasses in the first period of the crossover and high power (57 prism diopter) peripheral prism glasses in the second period
Interventions
All patients will wear two pairs of prism glasses in a crossover design: the high power peripheral prism glasses and sham peripheral prism glasses. Each pair of prism glasses will be worn for four weeks
Low power (5 prism dioptre) prism glasses that provide only about 2 degrees of visual field expansion.
Eligibility Criteria
You may qualify if:
- At least 18 years of age.
- Sighted in both eyes, with monocular visual acuity (best corrected vision), of at least 20/50 in each eye.
- Complete homonymous hemianopia of more than 3 months duration
- Refractive error within the -5 dioptre to +5 dioptre range
- No significant cognitive impairment
- No history of wearing the Peli system of peripheral prisms for hemianopic field expansion (patients who have worn another type of prismatic correction for hemianopia such as yoked prisms or the Gottlieb VAS system can participate in the study)
- No physical or mental disabilities, including cognitive dysfunction, balance problems or other deficits that could impair ability to walk or use the peripheral prism spectacles.
- Able to walk (using a cane or walker is OK) or control the movements of their own wheelchair.
- In sufficiently good health to attend four in-office visits.
You may not qualify if:
- Diagnosis of dementia
- Diagnosis of visual neglect
- History of seizures in the last 6 months
- Incomplete hemianopia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexandra Bowerslead
- Chadwick Optical Inc.collaborator
- National Eye Institute (NEI)collaborator
Study Sites (13)
UAB Center for Low Vision Rehabilitation
Birmingham, Alabama, 35294, United States
Vista Center for the Blind and Visually Impaired
Palo Alto, California, 94306, United States
Visual Health@Jupiter Eye Center
Jupiter, Florida, 33458, United States
Emory Optical Low Vision
Atlanta, Georgia, 30322, United States
Illinois Eye Institute
Chicago, Illinois, 60616, United States
Indiana University School of Optometry, Low Vision Rehabilitation and Primary Care Services
Bloomington, Indiana, 47404, United States
University of Kansas Medical Center
Prairie Village, Kansas, 66208, United States
Schepens Eye Research Institute
Boston, Massachusetts, 02114, United States
Vision Care Specialists, P.C.
Southborough, Massachusetts, 01772, United States
Academy Eye Associates
Durham, North Carolina, 27707, United States
Seven Lakes Eye Care
West End, North Carolina, 27376, United States
NSU Oklahoma College of Optometry,
Tahlequah, Oklahoma, 74464, United States
Manchester Royal Eye Hospital
Manchester, M60 1QD, United Kingdom
Related Publications (3)
Peli E. Field expansion for homonymous hemianopia by optically induced peripheral exotropia. Optom Vis Sci. 2000 Sep;77(9):453-64. doi: 10.1097/00006324-200009000-00006.
PMID: 11014672BACKGROUNDBowers AR, Keeney K, Peli E. Community-based trial of a peripheral prism visual field expansion device for hemianopia. Arch Ophthalmol. 2008 May;126(5):657-64. doi: 10.1001/archopht.126.5.657.
PMID: 18474776BACKGROUNDBowers AR, Keeney K, Peli E. Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia. JAMA Ophthalmol. 2014 Feb;132(2):214-22. doi: 10.1001/jamaophthalmol.2013.5636.
PMID: 24201760DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alex Bowers
- Organization
- Schepens Eye Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Alex R Bowers, PhD
Schepens Eye Research Institute
- PRINCIPAL INVESTIGATOR
Karen Keeney, MSBA
Chadwick Optical Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 28, 2007
First Posted
July 2, 2007
Study Start
September 1, 2007
Primary Completion
July 1, 2009
Study Completion
April 1, 2010
Last Updated
April 4, 2017
Results First Posted
September 13, 2013
Record last verified: 2017-04