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Clinical Trials/CTRI/2025/04/083890
CTRI/2025/04/083890
Not yet recruiting
Not Applicable

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

Dr Arpita Jain1 site in 1 country50 target enrollmentStarted: April 24, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Arpita Jain
Enrollment
50
Locations
1
Primary Endpoint
1.Demographic data, history of smoking and comorbidities, systemic thyroid status, orbitopathy status
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patient willing to participate in study,willing for ocular examination and giving written informed consent.
  • •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.

Exclusion Criteria

  • •Patient in whom diagnosis is uncertain
  • •Patient with associated ocular myasthenia
  • •Patient with orbital tumors, myositis, pseudotumor, cellulitis.

Outcomes

Primary Outcomes

1.Demographic data, history of smoking and comorbidities, systemic thyroid status, orbitopathy status

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Arpita Jain
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Arpita Jain

Sawai Man Singh Medical College and Hospital

Study Sites (1)

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