| CTRI Number |
CTRI/2021/06/034427 [Registered on: 28/06/2021] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of facial measurements with spectacles worn among Downs syndrome children |
|
Scientific Title of Study
|
Evaluation of craniofacial Anthropometric measurements with spectacles worn among Downs syndrome children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namratha |
| Designation |
Asst.Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Signal, Bangalore
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Signal, Bangalore
Bangalore
KARNATAKA
560 037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namratha |
| Designation |
Asst.Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Signal, Bangalore
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Signal, Bangalore
Bangalore
KARNATAKA
560 037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namratha |
| Designation |
Asst.Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Signal, Bangalore
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Signal, Bangalore
Bangalore
KARNATAKA
560 037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Signal, Bangalore |
| 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 |
| Namratha |
Sankara Eye Hospital |
Department of Optometry, Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Signal, Bangalore
Bangalore
KARNATAKA |
9986266576
namratha.hegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q909||Down syndrome, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric Down s syndrome patients who are wearing spectacles currently |
|
| ExclusionCriteria |
| Details |
Any active disease causing abnormal facial changes other than Down s syndrome and with any active ocular infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Craniofacial anthropometric measurements of Down s syndrome patients compared with their with spectacle measurements |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compliance to spectacle wear among Downs syndrome patients |
one year |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective study which aims to evaluate the craniofacial anthropometric measurements among spectacles worn Downs syndrome children. This study will be recruiting children in the age group of 5-17 years. The primary outcome is to understand whether the spectacles worn by Downs syndrome children meets their craniofacial measurements or not. The secondary outcome is to estimate the compliance towards spectacle wear among Down s syndrome children. This study will be beneficial to understand if these children are wearing face appropriate spectacle, if not the study results will be helpful in directing them towards the optimal spectacle wear. Optimal spectacle wear will definitely improve their visual functions along with the quality of life. |