The design and construction of a lens is heavier than ordinary lenses and its effect on the parameters of nystagmus evoked by optocentric stimulation in healthy young people and its generalization in the treatment of people with vertigo.
Design
A control clinical trial with parallel groups was performed on 32 patients with and without lenses (conventional and weighted).
Settings and conduct
This study will be done to evaluate the effect of weighted lens designed for nystagmus suppression and reduction of dizziness in the balance system evaluation clinic of Shahid Beheshti School of Rehabilitation Sciences in two stages (test-retest)(two weeks apart )using VNG test .
Participants/Inclusion and exclusion criteria
Age range between 18 and 25 years
Absence of vision problems and ocular motor muscles
Absence of neurological and psychological problems
Do not use drugs that affect the central system during the 48 hours before the test
Do not use caffeine and alcohol for 48 hours before the test
Absence of any spontaneous nystagmus
Reluctance to cooperate for any reason
Inability to perform the test for any reason
Intervention groups
Without lens(control)- with conventional lens - with weighted lens
Main outcome variables
Vertigo- Nystagmus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220119053761N1
Registration date:2022-02-02, 1400/11/13
Registration timing:prospective
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
Majid Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1721
Email address
m_ashrafi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of weighted contact lens on physiological nystagmus in young normal people
Public title
The effect of weighted contact lens on physiological nystagmus in young normal people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 18 and 25 years - No vision problems and eye movement muscles - No neurological and psychological problems - No use of drugs affecting the central system during the 48 hours before the test - No use of caffeine and alcohol in the 48 hours before the test - Absence of any spontaneous nystagmus
Exclusion criteria:
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
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
Research Ethics Committees of Vice- Chancellor in Research Affairs- Shahid Beheshti University of M
Street address
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-01-09, 1400/10/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.711
Health conditions studied
1
Description of health condition studied
Vertigo
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Decrease of nystagmus SPV
Timepoint
At the beginning of the study and repeat it two weeks later
Method of measurement
videonystagmography(VNG) test
Secondary outcomes
1
Description
Reduce of vertigo
Timepoint
During the initial evaluation and two weeks later
Method of measurement
VNG test
Intervention groups
1
Description
Intervention group: Using a weighted and conventional lens
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
school of Rehabilitation Sciences Shahid Beheshti
Full name of responsible person
Majid Ashrafi
Street address
Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
m_ashrafi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
افشین زرقی
Street address
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Ashrafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
m_ashrafi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Ashrafi
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences-Department of Audiology
City
Tehran
Province
Tehran
Postal code
161691311
Phone
+98 21 7756 1721
Email
m_ashrafi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Ashrafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences-Department of Audiology
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
m_ashrafi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no prohibition on using the data for practical use of the manufactured lens
From where data/document is obtainable
By e-mail to m_ashrafi@sbmu.ac.ir
What processes are involved for a request to access data/document
After sending the request to the university email, the data will be sent within two working days