| CTRI Number |
CTRI/2025/06/089855 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Anterior segment OCT for diagnosing early-onset childhood glaucoma |
|
Scientific Title of Study
|
Evaluation of Swept Source Anterior Segment Optical Coherence Tomography (SS ASOCT) as a Non-Invasive In Office Diagnostic Modality For Early Childhood Glaucoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmita Kaushik |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Room No 116 , Advanced Eye Centre , Postgraduate Institute of Medical Education and Research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
134109
India |
| Phone |
9814813207 |
| Fax |
01722756112 |
| Email |
sushmita_kaushik@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivangi Yadav |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Room No. 110
Advanced Eye Center
Postgraduate Institute of Medical Education and Research
Room No. 110
Advanced Eye Center
Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8755303016 |
| Fax |
|
| Email |
yshivangi15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushmita Kaushik |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Room No 116 , Advanced Eye Centre , Postgraduate Institute of Medical Education and Research
Sector 12
Chandigarh
CHANDIGARH
134109
India |
| Phone |
9814813207 |
| Fax |
01722756112 |
| Email |
sushmita_kaushik@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research
Chandigarh
|
|
|
Primary Sponsor
|
| Name |
Medical Education Cell Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Postgraduate Institute of Medical Education and Research Chandigarh |
| 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 Sushmita Kaushik |
Postgraduate Institute of Medical Education and Research Chandigarh |
Room No 116 Advanced Eye Centre,
Postgraduate Institute of Medical Education and Research Chandigarh
Chandigarh
CHANDIGARH |
9814813207
01722756112
sushmita_kaushik@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H408||Other glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
CASES: 1 day - 5 years of non acquired childhood Glaucoma as per CGRN classification
CONTROLS: Age matched controls with NLDO
Age matched controls with emmetropic eye
of strabismic patient
Age matched control of normal eye of
strabismic patient |
|
| ExclusionCriteria |
| Details |
CASES: Children with secondary Glaucoma
Children with ocular trauma
Children with previous history of any
ocular surgery
CONTROLS: Children with ocular trauma
Children with previous history of any
ocular surgery
Children with retinal pathologies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnosing Childhood Glaucoma based on the appearance of Trabecular Meshwork visibility on SS ASOCT captured in office without any sedation compared to standard examination under anesthesia |
8 week
At the time of EUA to assess the anterior chamber parameters on ASOCT when the definitive diagnosis of glaucoma is made, and then compare it to non-glaucomatous children |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of Anterior Chamber Angle parameters Angle opening distance AOD 250 , AOD 500, Angle Recess Area ARA 250, ARA 500 |
8 week At the time of EUA to assess the anterior chamber parameters on ASOCT when the definitive diagnosis of glaucoma is made, & then compare it to non-glaucomatous children |
| To study whether the ASOCT findings in glaucomatous children correlates to the phenotype of glaucoma |
8 week At the time of EUA to assess the anterior chamber parameters on ASOCT when the definitive diagnosis of glaucoma is made, & then compare it to non-glaucomatous children |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
11/07/2025 |
| 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="1"
Days="1" |
|
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
|
It will be an observational prospective study including children of 1 day to 5 years of age. 2 groups will be formed . Group 1 will include children 1 day to 5 years of age diagnosed with non acquired childhood glaucoma as per the CGRN criteria will be considered as cases Group 2 will include the age matched control of children diagnosed with CNLDO other eye of amblyopic patient other eye of squint patient will be considered as controls - SS ASOCT will be performed in children fulfilling the inclusion criteria in both the groups as a part of routine ophthalmic examination in office non invasive procedure without any sedation using flying baby technique
- Visibility of trabecular meshwork TM will be graded as Grade 1 for TM visible Grade 2 for indeterminate TM Grade 3 for TM not visible
- Grade 1 will be considered as non glaucomatous children Grade 2 and 3 TM will be considered as glaucomatous
- Anterior chamber angle ACA parameters like AOD ARA will be compared between glaucomatous children and age matched controls.
- Examination under anesthesia EUA will be done for cases only to make a definitive diagnosis of glaucoma
- Comparison of Sensitivity Specificity Positive Predictive value of SS ASOCT in comparison to standard EUA to diagnose childhood glaucoma based on visibility of trabecular meshwork.
This study will assess the utility of SS ASOCT as an in office non invasive non sedating diagnostic imaging modality to diagnose early childhood glaucoma from normal children. |