| CTRI Number |
CTRI/2025/07/091404 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Screening for eye inflammation in children suffering from joint related diseases |
|
Scientific Title of Study
|
Prevalence Of Uveitis in Pediatric Autoimmune Rheumatic Diseases (AIRD) and Autoinflammatory Diseases. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShabtab Nasir |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
L V Prasad Marg,
Banjara Hills, Road No: 02,
Hyderabad 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
8879335518 |
| Fax |
|
| Email |
shabtab.nasir@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShabtab Nasir |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
L V Prasad Marg,
Banjara Hills, Road No: 02,
Hyderabad 500034
TELANGANA
500034
India |
| Phone |
8879335518 |
| Fax |
|
| Email |
shabtab.nasir@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrShabtab Nasir |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute,
L V Prasad Marg,
Banjara Hills, Road No: 02,
Hyderabad 500034
TELANGANA
500034
India |
| Phone |
8879335518 |
| Fax |
|
| Email |
shabtab.nasir@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute, GPR building, Uvea department, 3rd floor,Room no :352, Banjara Hills, Road NO: 02, Hyderabad 500034, Telangana , India |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Banjara Hills, Road No: 02
Hyderabad 500034 |
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
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 |
| DrShabtab Nasir |
Nizams Institute of Medical Sciences |
Millineum Block, 1st floor, Room 107,Rheumatology department
Hyderabad
TELANGANA |
8879335518
shabtab.nasir@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H201||Chronic iridocyclitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 2-16 years diagnosed with any autoimmune rheumatic disease (Juvenile Idiopathic Arthritis (JIA), Autoinflammatory syndromes) |
|
| ExclusionCriteria |
| Details |
1.Children with infectious diseases.
2.Children with significant comorbidities unrelated to rheumatic conditions.
3.Children with poor vision due to other causes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Prevalence of uveitis in pediatric rheumatic and autoinflammatory disease patients.
2. Types of uveitis (anterior, intermediate, posterior, or panuveitis) in subsets of pediatric rheumatic diseases.
|
3 Months, 6 Months, 12 Months,18 Months, 24 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Association between levels of inflammatory markers (e.g., ESR, CRP) and the occurrence and severity of uveitis.
2.Correlation between disease activity scores in rheumatic diseases and uveitis occurrence.
|
3 Months, 6 Months, 12 Months,18 Months, 24 Months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/08/2025 |
| 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="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Uveitis is a known complication in pediatric autoimmune and autoinflammatory diseases, particularly in Juvenile Idiopathic Arthritis (JIA). Uveitis has been reported to contribute to 25% of cases of blindness in the developing world and about 3-10% in the Western world. Among uveitis patients, children comprise around 2.2-13.8% of the cases. Over a fifth of pediatric uveitis cases present with moderate/severe visual impairment, especially in older age or with prior oral corticosteroid therapy. Given the significant morbidity associated with uveitis, early screening and identification of uveitis are crucial in pediatric patients. To determine the prevalence and types of uveitis in children aged 2-16 years diagnosed with autoimmune rheumatic diseases (AIRD) and autoinflammatory diseases.
|