Biofeedback for Hemianopia Vision Rehabilitation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05397873|
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : May 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hemianopsia, Homonymous Brain Injury Stroke Brain Tumor Brain Trauma||Device: Biofeedback training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||A group of patients have the intervention and another group has control tests. The control group crosses over to the interventional group|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The assessor does not know if the patient is in the control group, treatment group or cross over group.|
|Official Title:||Biofeedback Training to Improve Fixation Stability, Visual Function Outcomes, and Quality of Life in Hemianopia Cases|
|Actual Study Start Date :||July 8, 2021|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2024|
Experimental: Group A
The patients will undergo baseline assessment and receive the intervention, being assessed after the intervention.
Device: Biofeedback training
The training of oculomotor functions is done on the biofeedback module of a microperimeter MAIA.
No Intervention: Group B
The patients will perform the same tests for assessment as in group A, however, no intervention will be done. They may enrol in the study as group B after completing group B participation.
- Visual Acuity [ Time Frame: 1 week post biofeedback ]ETDRS best corrected visual acuity
- Fixation stability [ Time Frame: 1 week post biofeedback ]As measure by the MAIA microperimeter at the BCEA 63% ellipse area.
- Retinal sensitivity [ Time Frame: 1 week post biofeedback ]Paracentral (2 central vertical columns) and total average in dB as measured by the MAIA microperimeter.
- Reading speed [ Time Frame: 1 week post biofeedback ]As measured with the MNRead charts
- Near vision [ Time Frame: 1 week post biofeedback ]Measured with the Colenbrander 100% charts
- Quality of Life Questionnaire scores [ Time Frame: 1 week post biofeedback ]As measured with the Massof - 48 questionnaire
- Stereopsis [ Time Frame: 1 week post biofeedback ]As measured with the Frisby stereotest
- Contrast Sensitivity [ Time Frame: 1 week post biofeedback ]As measured with the F.A.C.T. test at 1m
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05397873
|Toronto Western Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T2S8|
|Contact: MONICA DAIBERT NIDO, MD 4166035470 firstname.lastname@example.org|
|Contact: Monica Daibert Nido, MD 4164819995|