Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44EY014723 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chadwick Optical Inc. | INDUSTRY |
| National Eye Institute (NEI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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. The study will employ a crossover design in which each participant will wear a pair of real prism glasses (high-power, 57 prism diopter) and a pair sham prism glasses (low-power, 5 prism diopters, that provide little field expansion) in counterbalanced order. The efficacy of the real prism glasses relative to the sham prism glasses will be assessed for general mobility (walking). We expect that participants will prefer the real prism glasses over the sham prism glasses as the former will be more helpful for obstacle detection when walking.
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 real 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real prism glasses first, then sham | Experimental | Participants 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 | Experimental | Participants 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High power (57 prism diopter) peripheral prism glasses | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility Change Score (All Participants Who Completed Crossover) | Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alex R Bowers, PhD | Schepens Eye Research Institute | Principal Investigator |
| Karen Keeney, MSBA | Chadwick Optical Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Center for Low Vision Rehabilitation | Birmingham | Alabama | 35294 | United States | ||
| Vista Center for the Blind and Visually Impaired |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11014672 | Background | 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. | |
| 18474776 | Background | Bowers 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. |
| Label | URL |
|---|---|
| Dr Eli Peli's Vision Rehabilitation Lab at Schepens Eye Research Institute | View source |
Not provided
97 subjects were screened for eligibility of which 73 met the study criteria and were enrolled. The main reasons for not meeting the inclusion criteria were incomplete hemianopia and spatial neglect.
Participants were recruited at 13 study sites, including Dr. Peli's lab at Schepens, 11 vision rehabilitation clinics in the US, and one in the UK. The clinics included university, hospital and private-practice clinics. Each site recruited a median of 7 participants (range 3 to 12). Data were collected in the period October 2007 to January 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Real Prism Glasses Then Sham | Real prism glasses for 4 weeks followed by sham prism glasses for 4 weeks |
| FG001 | Sham Prism Glasses Then Real | Sham prism glasses for 4 weeks followed by real prism glasses for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Allocation |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low power sham peripheral prism glasses | Device | Low power (5 prism dioptre) prism glasses that provide only about 2 degrees of visual field expansion. |
|
| Evaluated after 4 weeks of wearing each type of prism glasses |
| Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term) | Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits). | Evaluated after 4 weeks of wearing each type of prism glasses |
| Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term) | Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility improvement scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits). | Evaluated after 4 weeks of wearing each type of prism glasses |
| 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 |
| 24201760 | Derived | Bowers 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| First Intervention |
|
|
| Second Intervention |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups allocated to receive real prism glasses first and sham prism glasses first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Duration of hemianopia | Median | Inter-Quartile Range | Months |
| ||||||||||||||||||||||
| Side of hemianopia | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only participants who completed the crossover were included in this analysis | Posted | Number | participants | Evaluated after 4 weeks of wearing each type of prism glasses |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mobility Change Score (All Participants Who Completed Crossover) | Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits). | Only participants who completed the crossover were included in this analysis | Posted | Mean | Standard Deviation | logits | Evaluated after 4 weeks of wearing each type of prism glasses |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term) | Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits). | This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and continued to wear prism glasses in the long term. | Posted | Mean | Standard Deviation | logits | Evaluated after 4 weeks of wearing each type of prism glasses |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term) | Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility improvement scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits). | This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and then discontinued wearing prism glasses. | Posted | Mean | Standard Deviation | logits | Evaluated after 4 weeks of wearing each type of prism glasses |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entire Study Population | Includes groups allocated to receive real prism glasses first and sham prism glasses first | 0 | 67 | 0 | 67 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex Bowers | Schepens Eye Research Institute | 617-912-2512 | alex_bowers@meei.harvard.edu |
| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001766 | Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
|
| Participants |
|
|
|
| Participants |
|
|
|