Trial Outcomes & Findings for Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children (NCT NCT03002597)

Results Overview

The efficacy endpoint for this study is a statistical analysis of subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception (BaGA testing), and standardized object recognition tasks after use of the BrainPort. The mean data reported is the average percentage that participants were able to successfully complete the tested tasks over the 5 visits.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

5 visits over the course of approximately 2 weeks

Results posted on

2023-08-16

Participant Flow

We were unable to enroll sighted children into the study

Participant milestones

Participant milestones
Measure	Blind Children Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider. BrainPort V200 Device: To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blind Children n=9 Participants Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider. BrainPort V200 Device: To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.
Age, Continuous	9.67 years n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 5 visits over the course of approximately 2 weeks

The efficacy endpoint for this study is a statistical analysis of subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception (BaGA testing), and standardized object recognition tasks after use of the BrainPort. The mean data reported is the average percentage that participants were able to successfully complete the tested tasks over the 5 visits.

Outcome measures

Outcome measures
Measure	Blind Children n=9 Participants Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider. BrainPort V200 Device: To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.
Evaluate BrainPort Device light perception	77.99 percentage of accuracy completing task Standard Deviation 34.99
Evaluate BrainPort Device location resolution	38.0 percentage of accuracy completing task Standard Deviation 20.09
Evaluate BrainPort Device BaGA testing	27.86 percentage of accuracy completing task Standard Deviation 15.14
Evaluate BrainPort Device object identification	77.36 percentage of accuracy completing task Standard Deviation 20.83
Evaluate BrainPort Device object location	65.47 percentage of accuracy completing task Standard Deviation 27.82

Adverse Events

Blind Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kanwal Nischal

Children's Hospital of Pittsburgh UPMC

Phone: 4126928940

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place