Clinical Trial of Peripheral Prism Glasses for Hemianopia

Study Overview
=================
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Community-based Multi-center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia

Conditions
-----------------
Homonymous Hemianopia

Intervention / Treatment
-----------------
* Device: High power (57 prism diopter) peripheral prism glasses
* Device: Low power sham peripheral prism glasses


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real prism glasses first, then sham<br>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 | Device: High power (57 prism diopter) peripheral prism glasses<br>* 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<br>Device: Low power sham peripheral prism glasses<br>* Low power (5 prism dioptre) prism glasses that provide only about 2 degrees of visual field expansion.<br>|
| Experimental: Sham prism glasses first, then real<br>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 | Device: High power (57 prism diopter) peripheral prism glasses<br>* 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<br>Device: Low power sham peripheral prism glasses<br>* Low power (5 prism dioptre) prism glasses that provide only about 2 degrees of visual field expansion.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemianopia, Mobility, Rehabilitation, Low vision