N/A
N=73
Clinical Trial of Peripheral Prism Glasses for Hemianopia
Homonymous Hemianopia
Bottom Line
View on ClinicalTrials.gov: NCT00494676 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Overall Proportion Saying "Yes" to Real Prism Glasses — 39; 22 participants — p== 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High power (57 prism diopter) peripheral prism glasses (Device); Low power sham peripheral prism glasses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alexandra Bowers
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Proportion Saying "Yes" to Real Prism Glasses |
39; 22 | = 0.001 sig |
| SECONDARY Mobility Change Score (All Participants Who Completed Crossover) |
1.9; 1.3 | = 0.09 |
| SECONDARY Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term) |
3.0; 1.1 | = 0.002 sig |
| SECONDARY Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term) |
1.1; 1.6 | = 0.21 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Diagnosis of dementia
- Diagnosis of visual neglect
- History of seizures in the last 6 months
- Incomplete hemianopia
Data sourced from ClinicalTrials.gov (NCT00494676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.