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CTRI Number  CTRI/2024/10/075901 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To test for the eye sight difficulties in Developmental brain problems 
Scientific Title of Study   Diagnostic Protocol for Perceptual Visual Difficulties in Children with Cerebral Visual Impairment  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sahithya Bhaskaran 
Designation  Medical Consultant  
Affiliation  Aravind Eye Hospital and Postgraduate Institute of Ophthalmology  
Address  Department of Paediatric ophthalmology and Strabismus Room No 150
1st Floor OPD Block No1 Anna Nagar
Madurai
TAMIL NADU
625020
India 
Phone  914524356100  
Fax    
Email  sahithya.dr@aravind.org  
 
Details of Contact Person
Scientific Query  
Name  Dr P Vijayalakshmi 
Designation  Chief 
Affiliation  Paediatric ophthalmology and strabismus 
Address  Room No 150 First floor
Block A No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India 
Phone  914524356100   
Fax  914522530984   
Email  p.vijayalakshmi@aravind.org  
 
Details of Contact Person
Public Query  
Name  Dr Sahithya Bhaskaran 
Designation  Medical Consultant  
Affiliation  Aravind Eye Hospital and Postgraduate Institute of Ophthalmology  
Address  Department of Paediatric ophthalmology and Strabismus Room No 150
1st Floor OPD Block No1 Anna Nagar
Madurai
TAMIL NADU
625020
India 
Phone  914524356100  
Fax    
Email  sahithya.dr@aravind.org  
 
Source of Monetary or Material Support  
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology Department of Paediatric ophthalmology and Strabismus Room No 150 1st Floor OPD Block No1 Anna Nagar Madurai 625020 TAMILNADU India 
 
Primary Sponsor  
Name  Maastricht University 
Address  Minderbroedersberg 4-6 6211 LK Maastricht The Netherlands 
Type of Sponsor  Research institution 
 
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 
Dr Sahithya Bhaskaran   Aravind Eye Hospital and Postgraduate Institute of Ophthalmology   Department of Paediatric ophthalmology and Strabismus Room No 150 1st Floor OPD Block No1 Anna Nagar
Madurai
TAMIL NADU 		 914524356100
91452253098
sahithya.dr@aravind.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aravind Eye Hospital, Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F79||Unspecified intellectual disabilities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Children with features suggestive of CVI   One time intervention of 30 to 40 minutes duration 
Comparator Agent  Normally developing children  One time intervention of 30 to 40 minutes duration 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Study group
Children between 2 to 18 years with suspected features or risk of developing CVI
Children with neuroimaging reports
Children with an evaluation from a paediatric neurologist on systemic neurological diagnosis

Control group
Typically developing children who are -age matched
No risk factors predisposing to CVI neurological issues
Age appropriate milestone development 
 
ExclusionCriteria 
Details  Study group
Children already on CVI intervention strategies vision therapy
Children without a definite systemic diagnosis
Children without Neuroimaging
Children with acquired post traumatic CVI with onset after the first month of life

Control group
History of developmental delay prematurity or seizures
Children with ocular conditions like strabismus amblyopia cataract etc which may interfere with visual development 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The results of this study will aim in developing a standard protocol for reliably diagnosing and categorizing CVI  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Better understanding of CVI will aid in early diagnosis, planning appropriate intervention and aid in prognosis of the disease  12 months 
 
Target Sample Size   Total Sample Size="536"
Sample Size from India="536" 
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)   01/11/2024 
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="1"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Test group: Children with features suggestive of CVI, referred by a paediatric neurologist with systemic diagnosis will be taken as the test group. After IQ assessment/ Autism Score will be included in the study. All children will be assessed by paediatric neurologist, paediatric ophthalmologist, Rehabilitationist and optometrist. Children will be examined in the presence of their parents and caregivers/ special educators.

Control group :

Children between 2 to 18 years of age who are developmentally age matched to the test group will be taken as the control group.  Children with age appropriate development (as ascertained by history), no co occurring ocular or neurologic co mordbidity are recruited. These children are not required to undergo neuroimaging.

Both groups will undergo history, examination and the visuoperceptual or functional vision tests.

History: Antenatal and perinatal history will be documented. Challenges encountered by the child in day-to-day life, visual complaints, atypical visual behaviour, and learning will be documented.

Dr Dutton’s Mini CVI questionnaire consisting of 5 questions will also be documented. 6

Neuroimaging:

MRI findings will be characterised as brain maldevelopments, white matter (WM) lesions, grey matter (GM) lesions, miscellaneous abnormalities, or normal MRI7. 

Ocular Examination:

Standard ocular exams including visual acuity age and ability-appropriate charts will be used). Dynamic retinoscopy to assess accommodation will be performed 8. Cycloplegic retinoscopy, anterior segment and fundus will be performed. In case of refractive errors, best glasses will be prescribed.

Strabismus evaluation and binocular single-vision evaluation will be performed with best glasses.

Visuoperceptual (VP) tests:

Children who were nonverbal will assessed with the help of the caregiver or parent and a special educator. Each child will be asked to perform all tests demonstrated by the observer or special educator for at least 2 to 3 trials. Even after the trials, if the child cannot perform the test, the result will be recorded as “absent.” If the child did not attempt the test, it will be categorized as “not testable.” 9

Visual Perceptual tests based on the L94 protocol for 2 to 5-year-olds 10,11  and DTVP 3 testing methods for children more than 5 years 12  will be used. The tests will include fixation time, visual field, contrast, colour vision, visual discrimination, visual closure, form constancy, biological motion, saccades, pursuits, visual memory, figure-ground discrimination, visual agnosia, ataxia, reading performance etc will be assessed. VP tests will be categorised for dorsal and ventral streams.

Based on the pattern of difficulties in the test battery, we shall analyse if certain domains are specifically affected in certain neurological abnormalities. If VP tests can be used as a standard measure to diagnose the presence of CVI in a child. VP pattern will be correlated to MRI abnormalities to see if they are associated with or represent structurally abnormal areas.

 
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