Disappearance of Graves' Orbitopathy

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Disappearance of Graves' Orbitopathy in the Long Term

Conditions
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Thyroid Eye Disease

Intervention / Treatment
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* Diagnostic Test: Ophthalmological evaluation
* Diagnostic Test: Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ophthalmological evaluation|exophthalmometry, evaluation of the Clinical Activity Score (CAS), assessment of diplopia, measurement of visual acuity, assessment of the corneal status; examination of the fundi|
|Diagnostic Test: Questionnaire|Patients were asked to fill a questionnaire on self-perception related to GO with the following questions: i) are your eyes identical to the way they were before GO appeared?; ii) are your eyes normal? iii) do you have any limitations in daily activities related to your eyes?; iv) do you have any limitations in social life related to your eyes?|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance of GO | 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. | up to 18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective disappearance of GO | 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 | up to 18 years | 
| Subjective disappearance of GO | 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. | up to 18 years |