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CTRI Number  CTRI/2023/10/059207 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 22/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study of visual problems in children due to brain dysfunction in children with Neurodevelopmental Delay 
Scientific Title of Study   Cerebral Visual Impairment in Children with Neurodevelopmental Delay 
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 Vijaya Pai H 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9845426427  
Fax    
Email  paivijaya@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Samyak Kalamkar 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal. 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7507776554  
Fax    
Email  samyakkalamkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Samyak Kalamkar 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal. 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7507776554  
Fax    
Email  samyakkalamkar@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Dr Vijaya Pai H 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal 
Type of Sponsor  Other [Self] 
 
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 Vijaya Pai H  Kasturba Medical College  OPD building, 2nd Floor, Department of Ophthalmology, Kasturba Medical College, Madhavnagar, Manipal. 576104
Udupi
KARNATAKA 		 9845426427

paivijaya@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H479||Unspecified disorder of visual pathways,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Children referred or recruited from Paediatrics OPD/Ward and walk in patients in Ophthalmology OPD with neurodevelopmental delay. 
 
ExclusionCriteria 
Details  Parents not consenting for the study. Children more than 6 years of age. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnosing patients with neurodevelopmental delay with Cerebral Visual Impairment and understanding the prevalence of Cerebral Visual Impairment in patients with neurodevelopmental delay.  End of sample collection. 
 
Secondary Outcome  
Outcome  TimePoints 
Understanding the prevalence of Cerebral Visual Impairment in patients with neurodevelopmental delay.  End of sample collection. 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   01/11/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Cerebral visual impairment (CVI) is defined as vision loss resulting from post-chiasmatic damage, in the absence of damage to the anterior afferent visual pathways or ocular structures, or vision loss that is greater than expected for the degree of ocular pathology. CVI is the leading cause of childhood visual disability in developed countries and the relative prevalence is increasing due to successful management of childhood blindness resulting from cataract and retinopathy of prematurity. In addition, increasing survival of children with brain injury has contributed to an increased incidence of CVI. Among children with visual dysfunction Nielsen et al. (2007a) found CVI in 48 out of 97 children; this corresponds to 49.5 %. The most frequent aetiologies for CVI in the Linz study was perinatal hypoxia or hypoxia in preterm children (56.3 %), followed by morphological disorders of brain development (28 %). In ~30 % the aetiology of abnormal brain development was of prenatal origin, in ~60 % of peri-natal, and in ~10 % of postnatal origin. At the time of assessment, about 15 % of children were younger than 2 years; about 70 % of children were between 3 and 5 years old and about 15 % were older than 5 years. More than half of the children (55 %) showed optic nerve atrophy; about two-thirds suffered from epilepsy. Visual Acuity is commonly reduced in CVI but can be normal. Binocular visual acuity gives an indication of the limitations of visual function. Unilateral brain damage is associated with homonymous hemianopia, which may be complete or incomplete. Damage to the optic radiations superior to the lateral ventricles leads to lower visual field loss. Children with cerebral visual impairment commonly have bilateral lower visual field impairment if there has been superior periventricular damage affecting the visual pathways. Impaired ability to see multiple targets at the same time results in impaired attention. In addition, a disability to estimate depth, particularly for moving the feet through depth, can lead to injury. Perception of movement is subserved bilaterally by cerebral tissue called the middle temporal lobes, which are found anterior to the visual cortex. Damage to this area on both sides can lead to impaired or even absent perception of movement. Only the static visual world can be seen and appreciated. Children with dorsal stream dysfunction can show many features related to dysfunction in this area, which causes difficulty in handling complex visual scenes. Ventral stream dysfunction associated with difficulty recognizing faces is a common feature of damage in the temporal lobe territory. Ventral stream dysfunction associated with difficulty recognizing faces is a common feature of damage in the temporal lobe territory. Social Interaction: People in a crowd or in the distance, may bedifficult to recognise. It tends to be difficultty perform more than one task at a time like talking and walking. Some children get distressed or angry or may even react violently when other restless children in the class-room cause distraction and this may be misconstrued as ‘bad behaviour’. These features can be isolating for the child. A study was done to evaluate causes for profound visual impairment in children ≤3 years of age at a tertiary eye care center in Andhra Pradesh, India. It revealed the causes of visual impairment were CVI in 33%, a combination of CVI and ocular visual impairment (OVI) 11%, and OVI only 56%. Delays in different areas of development were seen with CVI (72.5%), which included motor delay (51.5%), cognitive delay (14.6%), speech delay in (2.9%), and delay in multiple areas of development (like combination of motor, cognitive, and speech delay) in (31.1%). The patients referred/recruited from paediatrics department with neurodevelopmental delay as well as walk in patients in Ophthalmology OPD with Neurodevelopmental delay will be selected for the study. After taking due consent from the parents/guardians of the children with diagnosed/suspected neurodevelopmemntal delay, they will be given the PQCVI(Parentral questionnaire for Cerebral Visual Impairment) and baseline demographic characteristics will be obtained. The scores of the questionnaire will be calculated by an ophthalmologist. If the score for the child is below 2SD compared with the age appropriate normative scores, the child will be given further age appropriate ophthalmological evaluation.The Parentral questionnaire in CVI which will be used produced reliable responses in children younger than 72 months. The rapid increase in scores before the age of 3 years supports the importance of early identification of CVI. Thus, the above studies point out that Cerebral Visual Impairment in Children is an underdiagnosed condition, has multiple etiologies and causes varied manifestations. The early detection and treatment is important for the better prognostic chances for the child. 
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