Trial Outcomes & Findings for Multiplexing Prism Fitting for Field Expansion of Monocular Vision (NCT NCT06027216)
NCT ID: NCT06027216
Last Updated: 2025-05-08
Results Overview
Field expansion is calculated based on the difference of the maximum field of view on the nasal side of the seeing/functioning eye (same side as the blind eye) with and without multiplexing prism.
COMPLETED
NA
30 participants
Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
2025-05-08
Participant Flow
Participant milestones
| Measure |
Enrolled Participants for Multiplexing Prism
Of the 30 enrolled participants, 22 met the inclusion criteria and were prescribed with the multiplexing prism.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Enrolled Participants for Multiplexing Prism
Of the 30 enrolled participants, 22 met the inclusion criteria and were prescribed with the multiplexing prism.
|
|---|---|
|
Overall Study
Did not qualify
|
8
|
Baseline Characteristics
Multiplexing Prism Fitting for Field Expansion of Monocular Vision
Baseline characteristics by cohort
| Measure |
Patient's Demography
n=22 Participants
Adult individual with acquired monocular vision (seeing with one eye)
|
|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Nasal Visual Field of the Seeing/Functioning Eye
|
55 degree
STANDARD_DEVIATION 4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)Field expansion is calculated based on the difference of the maximum field of view on the nasal side of the seeing/functioning eye (same side as the blind eye) with and without multiplexing prism.
Outcome measures
| Measure |
Amount of Visual Field Expansion
n=22 Participants
The maximum field of view on the nasal side (same side as the blind eye) of the participants with and without the multiplexing prism is measured. An increase in visual field indicates field expansion/gain.
|
|---|---|
|
Gain in Visual Field With the Multiplexing Prism
|
24 degrees
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)The farthest extent of the nasal visual field with the multiplexing prism placed in front of the seeing eye.
Outcome measures
| Measure |
Amount of Visual Field Expansion
n=22 Participants
The maximum field of view on the nasal side (same side as the blind eye) of the participants with and without the multiplexing prism is measured. An increase in visual field indicates field expansion/gain.
|
|---|---|
|
Maximum Extent of Nasal Visual Field With the Multiplexing Prism
|
79 degrees
Standard Deviation 5
|
Adverse Events
Patient's Demography
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eli Peli
Schepens Eye Research Institute, Mass Eye and Ear
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place