The objective of current study is to evaluate the efficacy of Transcleral stimulation therapy for parienets with Retinitis pigmentasa.This research is a before and after interventional study.Participations are RP patient with inclusion criteria consist of VA better than 0.05,Age between 18-50 and exlusion critria;Comorbidity like cataract,diabet,Ocular surface or any ocular surgery. After getting informed consent from 25 patients ,Visual Acuity ، Optical Coherence Topography Electroretino graphy،fundus photo Dynamic Perimetry and complete eye exam will done as well as visual Function. Transcleral stimulation therapy will conduct for each eyes based on okuvision protocol. All above parameters will measured after 3,6 and 12 weeks and VA will evaluated weekly. success rate considered as 2 line improvement in VA after 3 month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401299820N6
Registration date:2017-02-20, 1395/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Alireza Lashay
Name of organization / entity
Eye research center
Country
Iran (Islamic Republic of)
Phone
+98 21 5512 1002
Email address
lashay@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Transcleral stimulation therapy (TES) for parienets with Retinitis pigmentasa
Public title
Efficacy of stimulation therapy for parienets with Retinitis pigmentasa
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion critria:Age between 18-50 ;RP detection with VA better than 0.05
Exlusion critria:Comorbidity like cataract,diabet,Ocular surface or any ocular surgery
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Enghelab Square
City
Teharn
Postal code
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
IR.TUMS.REC.1395.2874
Health conditions studied
1
Description of health condition studied
Transcleral Stimulation
ICD-10 code
H35.5
ICD-10 code description
Hereditary retinal dystrophy
Primary outcomes
1
Description
Visual Acuity
Timepoint
12 week
Method of measurement
Snellen Chart
Secondary outcomes
1
Description
Visual Function
Timepoint
12 week
Method of measurement
Questionair
Intervention groups
1
Description
Transcleral Stimulation based on specific protocol for each person in 20 min
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Eye Research Center,Tehran University of Medical Sciences
Full name of responsible person
Dr Elham Ashrafi
Street address
Farabi Hospital,Qazvin Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Alireza Lashay
Street address
Farabi Hospital,Qazvin Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Farabi Eye Research Center,Tehran University of Medical Sciences
Full name of responsible person
Dr Elham Ashrafi
Position
Professor Assistant
Other areas of specialty/work
Street address
Farabi Hospital,Qazvin Square
City
Tehran
Postal code
Phone
+98 21 5542 1001
Fax
Email
El.Ashrafi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farabi Eye Research Center,Tehran University of Medical Sciences
Full name of responsible person
Alireza Lashay
Position
Professor
Other areas of specialty/work
Street address
Farabi Hospital,Qazvin Square
City
Tehran
Postal code
Phone
+98 21 5542 1002
Fax
Email
lashay@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Farabi Eye Research Center,Tehran University of Medical Sciences
Full name of responsible person
Elham Ashrafi
Position
Professor Assisstant
Other areas of specialty/work
Street address
Farabi Hospital,Qazvin Square
City
Tehran
Postal code
Phone
+98 21 5542 1002
Fax
Email
El.Ashrafi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)