Trial Outcomes & Findings for Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia (NCT NCT04827147)
NCT ID: NCT04827147
Last Updated: 2026-08-19
Results Overview
Improvement in detection rate with prism glasses for hazards approaching from the blind side at a bearing angle of 40 degrees in the VR walking simulator test. Improvement is a binary outcome, defined as blind-side detection rate (number of pedestrians detected as a percentage of the total number of pedestrian events) which is significantly higher (z-test for two proportions) with than without prism glasses at the same visit.
COMPLETED
NA
64 participants
Immediately after each 4-week intervention
2026-08-19
Participant Flow
Participants were recruited between April 2023 and November 2024 at seven vision rehabilitation clinics in the United States, including three university clinics, three academic medical centers and one private practice.
64 participants were screened. 26 did not meet eligibility criteria and were excluded All 38 participants who met eligibility criteria were allocated to receive either MPP first (n=19) or FPP first (n=19). One allocation was mistakenly swopped; therefore 18 participants started in the MPP first group and 20 in the FPP first group.
Participant milestones
| Measure |
MPP First, FPP Second
Participants in this arm received the MPP in the first period of the crossover and the FPP in the second period.
|
FPP First, MPP Second
Participants in this arm received the FPP in the first period of the crossover and the MPP in the second period.
|
|---|---|---|
|
First crossover period
STARTED
|
18
|
20
|
|
First crossover period
COMPLETED
|
17
|
17
|
|
First crossover period
NOT COMPLETED
|
1
|
3
|
|
Second crossover period
STARTED
|
17
|
17
|
|
Second crossover period
COMPLETED
|
16
|
16
|
|
Second crossover period
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
MPP First, FPP Second
Participants in this arm received the MPP in the first period of the crossover and the FPP in the second period.
|
FPP First, MPP Second
Participants in this arm received the FPP in the first period of the crossover and the MPP in the second period.
|
|---|---|---|
|
First crossover period
Withdrawal by Subject
|
1
|
3
|
|
Second crossover period
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia
Baseline characteristics by cohort
| Measure |
MPP First, FPP Second
n=18 Participants
Participants in this arm received the MPP in the first period of the crossover and the FPP in the second period.
|
FPP First, MPP Second
n=20 Participants
Participants in this arm received the FPP in the first period of the crossover and the MPP in the second period.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 Years
n=298 Participants
|
57 Years
n=102 Participants
|
57 Years
n=400 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=298 Participants
|
7 Participants
n=102 Participants
|
11 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=298 Participants
|
13 Participants
n=102 Participants
|
27 Participants
n=400 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=298 Participants
|
2 Participants
n=102 Participants
|
6 Participants
n=400 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=298 Participants
|
15 Participants
n=102 Participants
|
29 Participants
n=400 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
3 Participants
n=102 Participants
|
3 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=298 Participants
|
3 Participants
n=102 Participants
|
5 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=298 Participants
|
17 Participants
n=102 Participants
|
33 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
PRIMARY outcome
Timeframe: Immediately after each 4-week interventionPopulation: An intention to treat analysis was used including all 38 participants who started the first period of the crossover. Participants who withdrew before the end of the second period of the crossover were entered into the analysis as no improvement with FPPs and no improvement with MPPs.
Improvement in detection rate with prism glasses for hazards approaching from the blind side at a bearing angle of 40 degrees in the VR walking simulator test. Improvement is a binary outcome, defined as blind-side detection rate (number of pedestrians detected as a percentage of the total number of pedestrian events) which is significantly higher (z-test for two proportions) with than without prism glasses at the same visit.
Outcome measures
| Measure |
All Participants Who Were Allocated
n=38 Participants
Includes all participants in the two treatment allocation groups (i.e. data are pooled across the two groups)
|
|---|---|
|
Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 40 Degrees
Improved with MPPs
|
12 Participants
|
|
Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 40 Degrees
Improved with FPPs
|
10 Participants
|
SECONDARY outcome
Timeframe: Immediately after each 4-week interventionPopulation: An intention to treat analysis was used including all 38 participants who started the first period of the crossover. Participants who withdrew before the end of the second period of the crossover were entered into the analysis as no improvement with FPPs and no improvement with MPPs.
Improvement in detection rate with prism glasses for hazards approaching from the blind side at a bearing angle of 20 degrees in the VR walking simulator test. Improvement is a binary outcome, defined as blind-side detection rate (number of pedestrians detected as a percentage of the total number of pedestrian events) which is significantly higher (z-test for two proportions) with than without prism glasses at the same visit.
Outcome measures
| Measure |
All Participants Who Were Allocated
n=38 Participants
Includes all participants in the two treatment allocation groups (i.e. data are pooled across the two groups)
|
|---|---|
|
Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 20 Degrees
Improved with MPPs
|
14 Participants
|
|
Improvement in Blind-side Detection Rate for Hazards Approaching at a Bearing Angle of 20 Degrees
Improved with FPPs
|
16 Participants
|
SECONDARY outcome
Timeframe: Immediately after the second 4-week interventionNumber of participants selecting each device as a percentage of the total number of participants enrolled
Outcome measures
| Measure |
All Participants Who Were Allocated
n=32 Participants
Includes all participants in the two treatment allocation groups (i.e. data are pooled across the two groups)
|
|---|---|
|
Device Preference
Preferred MPPs
|
13 Participants
|
|
Device Preference
Preferred FPPs
|
19 Participants
|
Adverse Events
MPP All Participants
FPP All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alex Bowers
Schepens Eye Research Institute of Mass Eye and Ear
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place