| CTRI Number |
CTRI/2025/04/083890 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Understanding Thyroid Eye Disease: A Study on Its Symptoms and Severity. This research explores common signs of the disease and key factors that influence its severity, helping improve awareness and patient care." |
|
Scientific Title of Study
|
An Observational Study to Describe the Clinical Features of Thyroid Eye Disease[TED] and to Identify the Factors Predictive of Disease Severity at SMS Medical College, Jaipur |
| 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 Arpita Jain |
| Designation |
PG Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
SAWAI MAN SINGH HOSPITAL JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
8003065083 |
| Fax |
|
| Email |
drarpitajain94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Hada |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh College and Hospital Jaipur |
| Address |
SAWAI MANSINGH HOSPITAL JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
9868765305 |
| Fax |
|
| Email |
mayahada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maya Hada |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh College and Hospital Jaipur |
| Address |
SAWAI MAN SINGH HOSPITAL JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
9868765305 |
| Fax |
|
| Email |
mayahada@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh Medical college and Hospital Jaipur |
|
|
Primary Sponsor
|
| Name |
Dr Arpita Jain |
| Address |
Surbhi Medicose Ganesh Colony Indergarh Road Karwar 323616 |
| 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 Arpita Jain |
SMS Hospital |
Department of ophthalmology CHARAK BHAWAN SMS hospital Jaipur
Jaipur
RAJASTHAN |
08003065083
drarpitajain94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee,S.M.S. Medical college and attached hospitals jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E05||Thyrotoxicosis [hyperthyroidism], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient willing to participate in study,willing for ocular examination and giving written informed consent.
2)Patient diagnosed as TED
a. If lid retraction is present with any of the following associations:
.presence of laboratory evidence of thyroid
dysfunction
.exophthalmos
.optic nerve dysfunction or
. extra ocular muscle involvement
b. If lid retraction is absent, then presence of laboratory evidence of thyroid dysfunction with any of the following:
. exophthalmos
. optic nerve involvement or
. extraocular muscle invovement |
|
| ExclusionCriteria |
| Details |
1. Patient in whom diagnosis is uncertain
2. Patient with associated ocular myasthenia
3. Patient with orbital tumors, myositis,
pseudotumor, cellulitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Demographic data, history of smoking and comorbidities, systemic thyroid status, orbitopathy status |
From July 2024 (after obtaining clearance from ethics committee) and once the sample size is achieved followed by time for statistical analysis or one year after beginning of study whichever is earlier |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/04/2025 |
| 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="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
|
We aim to study
the clinical profile based on the comprehensive VISA-ITEDS classification and
EUGOGO scoring which grades the disease activity and severity respectively. In
addition, we aim to identify risk factors that predict disease severity in TED
patients in our geographical region.
|