Disappearance of Graves' Orbitopathy

Completed

• Conditions: Thyroid Eye Disease

• Registration Number: NCT03103607
• Lead Sponsor: University of Pisa

Brief Summary

There is a general belief among physicians involved with Graves' orbitopathy (GO) that this syndrome is somehow "chronic", namely that the patient's eyes do not return the way they were before GO appeared.

The general impression that comes from the available studies is that the eyes of GO patients do not return to normal even after a very long time since the disease appearance under the physician's point of view, although a discrete proportion of patients feel so. However, no studies are available in which the issue was examined with both objective criteria and self-assessment.

The present study design was to investigated the disappearance of GO, regardless to treatment, in all consecutive patients with a history of GO of at least 10 years who came for a follow-up visit to our GO clinic over a period of 5 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2014-12-31
• Study Completion: 2016-02-28
• Status Verified: 2017-03
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Study First Posted: 2017-04-06
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• All GO patients with a GO history of at least 10 years who came for a follow-up visit in our GO clinic over a period of 5 consecutive years

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disappearance of GO	up to 18 years	Absence of objective signs and subjective symptoms of GO GO was considered disappeared when all the following criteria were fulfilled: objective criteria: i) exophthalmos ≤19 mm in men and ≤17 mm in women; ii) clinical activity score ≤1/7 points; iii) absence of diplopia; iv) normal visual acuity; v) normal corneal status; vi) no GO-related alterations of the fundi; subjective criteria (questionnaire): i) perception of both eyes identical to the way they were before GO appeared; ii) perception of both eyes as normal; iii) no eye-related limitation in daily activities; and iv) no eye-related limitations in social life.

Secondary Outcome Measures

Name	Time	Method
Objective disappearance of GO	up to 18 years	Absence of objective signs GO GO was considered disappeared when all the following criteria were fulfilled: i) exophthalmos ≤19 mm in men and ≤17 mm in women; ii) clinical activity score ≤1/7 points; iii) absence of diplopia; iv) normal visual acuity; v) normal corneal status; vi) no GO-related alterations of the fundi
Subjective disappearance of GO	up to 18 years	Absence of subjective symptoms of GO GO was considered disappeared when all the following criteria were fulfilled: i) perception of both eyes identical to the way they were before GO appeared; ii) perception of both eyes as normal; iii) no eye-related limitation in daily activities; and iv) no eye-related limitations in social life.