FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/02/023460 [Registered on: 20/02/2020] Trial Registered Retrospectively
Last Modified On: 19/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Vision therapy for Autism 
Scientific Title of Study   The effect of vision therapy in children with autism spectrum disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A Valarmathi 
Designation  Lecturer 
Affiliation  Sri Ramachandra University 
Address  No 15, G 3 Ganesh Flats, Pushpavathy Ammal Street, West Mambalam, Chennai.
No 1, Sri Ramachandra Nagar, Porur, Chennai - 600 116
Chennai
TAMIL NADU
600033
India 
Phone  9884757760  
Fax  044-24765995  
Email  avmathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Kalpana Suresh 
Designation  Professor 
Affiliation  Kalpana Eye Care 
Address  No 2, Boomadevi nagar, Gerugambakkam, Near Mahindra service station

Chennai
TAMIL NADU
600128
India 
Phone  9841226738  
Fax    
Email  kalpanasrao@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  A Valarmathi 
Designation  Lecturer 
Affiliation  Sri Ramachandra University 
Address  No 15, G 3 Ganesh Flats, Pushpavathy Ammal Street, West Mambalam, Chennai.
No 1, Sri Ramachandra Nagar, Porur, Chennai - 600 116

TAMIL NADU
600033
India 
Phone  9884757760  
Fax  044-24765995  
Email  avmathi@gmail.com  
 
Source of Monetary or Material Support  
India Vision Institute Plot No 212, New No 45, Palkalai Nagar, 7th Link Road, Palavakkam, Chennai - 600041  
Sri Ramachandra University and Research Institute, No 1 Ramachandra Nagar, Porur, Chennai 600116 
 
Primary Sponsor  
Name  India Vision Institute 
Address  Plot No 212, New No 45, Palkalai Nagar, 7th Link Road, Palavakkam, Chennai - 600041 
Type of Sponsor  Other [IVI supports research, education and industry development to elevate health care] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
A Valarmathi  Sri Ramachandra Medical College  Department of ophthalmology, G-Block, Second floor, Room No 17, No 1, Sri Ramachandra Nagar, Porur
Chennai
TAMIL NADU 
9884757760

avmathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Children with autism  The degree of change over a period of 15 weeks in those children who did not receive this treatment or who were in the waitlist group 
Intervention  Children with autism  Vision therapy focused towards improving visual spatial skills, visual motor skills and visual analytical skills would be provided for a period of 15 weeks in three phases of 5 weeks each 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  Children diagnosed to have Autism Spectrum disorder 
 
ExclusionCriteria 
Details  Subjects with a moderate to severe hearing loss, intellectually challenged subjects and emotionally disturbed subjects would be excluded from the study. Children residing in foster homes, or undergoing individualised education program or put to abuse or neglect will also be excluded from the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Developmental test of visual perceptual skills (DTVP-3) is the tool used pre and post vision therapy. Percentile improvement and improvement in age equivalence would be documented  DTVP - 3 Assessment will be done at the end of 16th week of vision therapy. Change in percentile improvement and change in age equivalence will be noted down 
 
Secondary Outcome  
Outcome  TimePoints 
The parameters that would be monitored are the improvement in attention, eye contact, changes in behavior assessed using a parent questionnaire  At the end of phase I, Phase II and Phase III 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/01/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   No publications yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Most people confuse the concept of vision. When there is no refractive error and no significant deficit in visual acuity measurement then the sensory organ for vision is assumed to be normal. However children with ASD face many challenges like poor eye contact, lack of social interaction, altered behaviour with the kith and kin’s and finally with the society at large. Paucity in a structured autism specific diagnostic and interventional service puts a lot of stress on the families with children on the ASD, in India, and abroad

 

Secondly looking into the various interventional therapies offered for children on the autism spectrum, most of the services are structured to handle all special children alike and the interventions are targeted to improve the proprioceptive (i.e., muscles and joints), vestibular (i.e., gravity and movement), and tactile (i.e., touch) systems as it is believed that they are the largest sensory system, most interconnected with other systems and the most utilised [Richard et al. 2008]. Global developmental therapies provided for children with autism spectrum disorder does not address specific deficiencies and difficulties and there are hardly any quantifiable feedback system designed, implemented and documented


Any intervention targeting children with ASD should be aimed at achieving specific developmental, behavioural and educational goals [Thomas KC et al, 2007]. A standardised protocol that measures each and every aspect of vision and visual perceptual skills is not available in our country. Having  understood the nuances behind the functioning of the eyes, meticulously determining and defining the deficit and working on specific deficits and finally integrating all the visual skills becomes the need of the hour and hardly any practitioner seems to be even aware of this concept.

As literature is devoid of standardised diagnostic protocols and therapeutic interventional methods with a quantitative feedback report a Vision Integration Trial for autism needs to be developed and implemented.


 
Close