Trial Outcomes & Findings for Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia (NCT NCT04827147)
NCT ID: NCT04827147
Last Updated: 2026-03-13
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.
ACTIVE_NOT_RECRUITING
NA
64 participants
Immediately after each 4-week intervention
2026-03-13
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=41 Participants
|
57 Years
n=39 Participants
|
57 Years
n=80 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=41 Participants
|
7 Participants
n=39 Participants
|
11 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=41 Participants
|
13 Participants
n=39 Participants
|
27 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=41 Participants
|
2 Participants
n=39 Participants
|
6 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=41 Participants
|
15 Participants
n=39 Participants
|
29 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
3 Participants
n=39 Participants
|
3 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants
|
3 Participants
n=39 Participants
|
5 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=41 Participants
|
17 Participants
n=39 Participants
|
33 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Immediately after each 4-week interventionImprovement 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 interventionImprovement 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