| CTRI Number |
CTRI/2024/06/068664 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing different ways of measuring the shape of the cornea in children using different devices while sitting and lying down |
|
Scientific Title of Study
|
A comparative study of keratometric measurements with portable Hand-Held automated keratometer in sitting and supine position with table mounted automated keratometer and IOL master in Pediatric age group |
| 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 USHA SIRIGIRI |
| Designation |
Fellow in Squint and Pediatric ophthalmology |
| Affiliation |
SANKARA EYE HOSPITALGUNTUR |
| Address |
Department of Squint and Pediatric Ophthalmology
Sankara Eye Hospital
Pedakakani
Guntur-Vijayawada Highway
Andhra Pradesh
INDIA
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9493039580 |
| Fax |
|
| Email |
usha245s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VANKIREDDI MAHATHI |
| Designation |
Consultant in Department of Squint and Pediatric ophthalmology |
| Affiliation |
SANKARA EYE HOSPITAL GUNTUR |
| Address |
Department of Squint and Pediatric Ophthalmology
Sankara Eye Hospital
Guntur-Vijayawada Highway
Pedakakani
Andhra Pradesh
INDIA
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9441575390 |
| Fax |
|
| Email |
mahathi.v.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr USHA SIRIGIRI |
| Designation |
Fellow in Squint and Pediatric ophthalmology |
| Affiliation |
SANKARA EYE HOSPITAL GUNTUR |
| Address |
Department of Squint and Pediatric Ophthalmology
Sankara Eye Hospital
Guntur-Vijayawada Highway
Pedakakani
Andhra Pradesh
INDIA
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9493039580 |
| Fax |
|
| Email |
usha245s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital
Guntur-Vijayawada Highway
Pedakakani
Andhra Pradesh
INDIA
Pin : 522509
|
|
|
Primary Sponsor
|
| Name |
Dr USHA SIRIGIRI |
| Address |
Sankara Eye Hospital
Guntur-Vijayawada Highway
Pedakakani
Andhra Pradesh
Pin:522509
INDIA |
| Type of Sponsor |
Other [SELF] |
|
|
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 USHA SIRIGIRI |
Sankara Eye Hospital |
Department Of Squint and Pediatric Ophthalmology
Guntur
ANDHRA PRADESH |
9493039580
usha245s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SankaraEyeHospitalGuntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. All Children between the age group of 5-15 years attending pediatric OPD at Sankara Eye Hospital Guntur from April 15 to September 15 2024 |
|
| ExclusionCriteria |
| Details |
1. Children younger than 5 years
2. Known Ocular Abnormalities like Nystagmus, Squint and Cataract
3. Any Conjunctival/ Corneal pathology like opacity or dystrophy
4. Any previous intraocular or extraocular surgery
5. Current / Previous contact lens wear
6. Uncooperative subjects |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Keratometry values with hand- held automated keratometer in sitting and supine position |
Every 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the variability of these measured K values with those of table mounted keratometer and IOL master |
Every 3 months |
|
|
Target Sample Size
|
Total Sample Size="369"
Sample Size from India="369"
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)
|
21/06/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is an observational cross -sectional study comparing keratometric measurements between portable hand held automated keratometer in sitting and supine position with table - mounted automated keratometer and IOL master in pediatric age group for a period of 6 months in 369 eyes of 5-15 years age group children attending pediatric OPD at Sankara eye hospital Guntur. Primary outcome measures will be to compare Keratometric values with Hand held automated keratometer in sitting and supine position for a period of 6 months . Secondary outcome measures will be to assess the variability of these measured K values with those of Table mounted keratometer and IOL master for a period of 6 months |