| CTRI Number |
CTRI/2024/03/063605 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out ophthalmic manifestations and their risk factors in children with developmental delay |
|
Scientific Title of Study
|
An Observational, cross sectional study, to find ophthalmic disorders and their risk factors in children with developmental delay at a tertiary centre in western India. |
| 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. Gayatri Pawar |
| Designation |
MBBS, DNB Ophthalmology Resident |
| Affiliation |
Bhaktivedanta hospital and research institute |
| Address |
Ophthalmology department,new building, 1st floor, Bhaktivedanta Hospital, Srishti complex, Bhaktivedanta Swami Marg , Mira Road East , Thane
Thane
MAHARASHTRA
401107
India |
| Phone |
8999586493 |
| Fax |
|
| Email |
gayatripawarrox@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna Kini |
| Designation |
MBBS, DNB OPHTHALMOLOGY , FCRS |
| Affiliation |
Bhaktivedanta Hospital and research institute |
| Address |
Ophthalmology department, new building, 1st floor, Bhaktivedanta Hospital, Srishti complex, Bhaktivedanta Swami marg , Mira Road East , Thane
Thane
MAHARASHTRA
401107
India |
| Phone |
9867600143 |
| Fax |
|
| Email |
sapnakini8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Pawar |
| Designation |
MBBS, DNB Ophthalmology Resident |
| Affiliation |
Bhaktivedanta Hospital and research institute |
| Address |
Ophthalmology department, new building, 1st floor, Bhaktivedanta Hospital, Srishti complex, Bhaktivedanta Swami Marg , Mira Road East , Thane
MAHARASHTRA
401107
India |
| Phone |
8999586493 |
| Fax |
|
| Email |
gayatripawarrox@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research institute,Shrishti Complex,Bhaktivedanta Swami Marg, Mira Road(East),Thane-401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and research institute |
| Address |
Bhaktivedanta Hospital and research institute, Srishti complex, Bhaktivedanta swami marg, Mira Road east Thane 401107 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayatri Pawar |
Bhaktivedanta Hospital and research institute |
Ophthalmology department, Opd no.3, New building Bhaktivedanta hospital Srishti complex, Bhaktivedanta Swami marg Mira Road east 401107
Thane
MAHARASHTRA |
8999586493
gayatripawarrox@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BhaktiVedanta Hospital Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H53-H54||Visual disturbances and blindness, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
- Children presenting to Ophthalmic OPD with a history of developmental delay
- Children between 1 year and 16 years of age
|
|
| ExclusionCriteria |
| Details |
- Those not willing to participate in this study
- Children who are very uncooperative for a detailed eye examination |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Find out ophthalmic manifestations in children with developmental delay.
2. To find out relative risk of various systemic conditions for corresponding ophthalmic manifestations. |
As this is an cross- sectional study, the outcomes will be assessed at the baseline that is at the time of initial presentation itself. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find out prevalence of optic atrophy in the examined children.
2.To find out prevalence of periventricular leucomalacia in children with MRI reports & it’s correlation with ophthalmic manifestations. |
As this is an cross sectional study, the study outcomes will be assessed at baseline, that is at the time of initial presentation itself. |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
11/03/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
All the children presenting to the ophthalmology OPD will undergo the following examinations and then will be categorized according to the inclusion criteria for further evaluation. Consent will be taken from the parents / guardian for the examination data of their child /ward to be included in the current study. Examination includes - * History taking (Informant will be parents / guardian) * Visual acuity (Age-appropriate tools will be used e.g. CSM method, Snellen visual acuity chart, Kay pictures, E chart etc) * Refraction - age-appropriate subjective as well as objective refraction * Slit lamp biomicroscopy * Pupillary reaction * Dilated Fundus examination * Assessment of Ocular alignment and Ocular Motility * Sensory evaluation and tests of stereopsis
ENDPOINTS- Children with developmental delay may have significant * Refractive errors * Nystagmus * Strabismus * Anisometropia * Visual impairment * Optic Atrophy After the detailed recording of data, statistical analysis is to be done. Relative risk will be calculated for the ophthalmic disorders like visual impairment, refractive errors and strabismus in relation to clinical conditions like birthweight, prematurity, birth asphyxia, cerebral palsy, epilepsy and genetic syndromes.
|