| CTRI Number |
CTRI/2025/12/099700 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative analysis of Astigmatism in Neurotypical and developmentally atypical infants |
|
Scientific Title of Study
|
Astigmatism in neurotypical and infants with developmental anomalies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Rani |
| Designation |
Phd scholar |
| Affiliation |
Sankara College of Optometry |
| Address |
Department of Optometry Room Number 9 Vipul world ferozpur road Ludhiana
Ludhiana
PUNJAB
141102
India |
| Phone |
9988174612 |
| Fax |
|
| Email |
poonam.chauhan5560@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditya Goyal |
| Designation |
Principal |
| Affiliation |
Sankara College of Optometry |
| Address |
Department of Optometry Room Number 9 Vipul world Ferozpur road Ludhiana
Ludhiana
PUNJAB
141102
India |
| Phone |
9988174612 |
| Fax |
|
| Email |
adityagoyal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Rani |
| Designation |
Phd scholar |
| Affiliation |
Sankara College of Optometry |
| Address |
Department of Optometry Room number 9 Vipul world Ferozpur road Ludhiana
Ludhiana
PUNJAB
141102
India |
| Phone |
9988174612 |
| Fax |
|
| Email |
poonam.chauhan5560@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Vipul world Firozpur road Ludhiana |
| 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 Aditya Goyal |
Sankara Eye Hospital |
Department of Optometry Room number 9 Vipul world Firozpur road Ludhiana
Ludhiana
PUNJAB |
09988174612
poonam.chauhan5560@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital Sri Kanchi Kamakoti Medical Trust Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H188||Other specified disorders of cornea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
A. Case group
Inclusion criteria
1.Birth weight less than 2.5kg
2.Gestational age less than 37 weeks
3.Medically stable infants
4.Infants diagnosed with Retinopathy of prematurity
B. Control Group
1. Birth weight more than 2.5kg
2. Gestation age more than 37 weeks
|
|
| ExclusionCriteria |
| Details |
A. Case Group
Exclusion Criteria 1. Corneal opacity
2.Cataract or any other anterior segment pathology
3. Infants with strabismus or nystagmus
B. Control group
Exclusion Criteria 1. Corneal opacity
2.Cataract or any other anterior segment pathology
3. Infants with strabismus or nystagmus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the type of astigmatism in infants with different term periods of birth.
To assess the type of astigmatism in infants with different birth weights.
To follow up on infants with preterm and low birth weight infants over a period of 6 monthly period to assess the type of astigmatism and any changes in it.
Assess and correlate the type of astigmatism with developmental anomalies.
|
Patient will be assessed at 1 month, 6 month and 12 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="324"
Sample Size from India="324"
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)
|
22/01/2026 |
| 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="0"
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 will evaluate astigmatism status in preterm and full term infants at 1 day 6 month and 12 month of birth time. The main aim of this study is to assess the type of astigmatism in infants with different term periods of birth and different birth weights and to follow up on infants with preterm and low birth weights infants over a period of 6 month to assess the type of astigmatism and any changes in it This study will also evaluate the correlation of astigmatism with developmental anomalies. The sample size would be 162 in each group of preterm and full term infants. |