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Evaluation of the effectiveness of the enhanced Brain Pert device on visual field observation, detection of black and white color contrast and sharpness of the visually impaired and blind

Protocol summary

Study aim
Evaluation of the effectiveness of the enhanced Brain Pert device on visual field observation, detection of black and white color contrast and sharpness of the visually impaired and blind
Design
Clinical trial with control group, with parallel groups, not blinded, on 30 patients
Settings and conduct
Patients who will come for eye examination will be referred to Heshmatieh Sabzevar Hospital, and then a list of visually impaired people who were between 20 and 50 years of age and who referred to Sabzevar Hospital in 2022 will be prepared. The criteria for diagnosing low vision will be an ophthalmologist. Their numbers will be contacted
Participants/Inclusion and exclusion criteria
Inclusion criteria: Failure to receive psychological treatment Patient consent to participate in the study - Lack of vision in a person is congenital Exclusion criteria: Oral lesions or cleft palate Structural and neurological disorders of the tongue -smoking -MR (mental retardation) The dissatisfaction of the person continuing the research
Intervention groups
There will be two groups (15 controls) and (15 experiments). Patients were introduced to the features of the BrainPort vision device, including turning the device on and off, field of view / zoom features, light intensity control, and inversion controls. We also showed maintenance issues such as how to replace the battery, how to take care of the device and troubleshooting solutions. The limitations of this technology were discussed, such as lack of color, lack of 3D depth perception, and that the stimulus is primarily a tactile perception. At the end of the sessions, due to ethical issues, 5 sessions of treatment will be performed on the control group. The next session of the informed consent form and pre-test will be performed.
Main outcome variables
Field of vision, black and white color contrast detection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101130005280N56
Registration date: 2022-07-09, 1401/04/18
Registration timing: registered_while_recruiting

Last update: 2022-07-09, 1401/04/18
Update count: 0
Registration date
2022-07-09, 1401/04/18
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of the enhanced Brain Pert device on visual field observation, detection of black and white color contrast and sharpness of the visually impaired and blind
Public title
Evaluation of the effectiveness of amplified Brain Pert device on visual field observation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Low vision on both sides and one side Having congenital low vision Disorders of the eyes or nerves of the visual pathway Failure to receive psychological treatment before entering the study Patient consent to participate in the research and to sign a written consent Low vision is not congenital
Exclusion criteria:
Low vision is not congenital Oral lesions or cleft palate Structural and neurological disorders of the tongue smoking MR (mental retardation) Individual dissatisfaction with continuing research
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Shohaday-e- Hasteei Blvd.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2022-03-15, 1400/12/24
Ethics committee reference number
IR.MEDSAB.REC.1400.190

Health conditions studied

1

Description of health condition studied
Low vision
ICD-10 code
H54.50
ICD-10 code description
Low vision, one eye, unspecified eye

Primary outcomes

1

Description
Field of vision
Timepoint
Baseline- end of treatment
Method of measurement
score of the FrACT questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First, a briefing session will be held for them and the purpose of the research and how to work with the device will be explained to him. Patients were introduced to the features of the BrainPort vision device, including turning the device on and off, field of view / zoom features, light intensity control, and inversion controls. We also showed maintenance issues such as how to replace the battery, how to take care of the device and troubleshooting solutions. The limitations of this technology were discussed, such as lack of color, lack of 3D depth perception, and that the stimulus is primarily a tactile perception.
Category
Treatment - Other

2

Description
Control group: At the end of the sessions, due to ethical issues, 5 sessions of treatment will be performed on the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Heshmatieh Hospital
Full name of responsible person
Ebrahim Shirzad
Street address
Sabzevar Heshmatieh Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9192264462
Phone
+98 903 926 4520
Email
raikaravan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Alireza Moslem
Street address
Address: Sabzevar - Sabzevar University of Medical Sciences - Vice Chancellor for Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
91961264714
Phone
+98 51 4401 1004
Email
raikaravan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ebrahim Shirzad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sabzevar University of Medical Sciences
City
sabzevar
Province
Razavi Khorasan
Postal code
9192264462
Phone
+98 51 4401 1004
Email
raikaravan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ebrahim Shirzad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sabzevar Heshmatieh Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9192264462
Phone
+98 903 926 4520
Email
raikaravan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ebrahim Shirzad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sabzevar Heshmatieh Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9192264462
Phone
+98 51 4401 1004
Email
raikaravan@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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