Disappearance of Graves' Orbitopathy

Thyroid Eye Disease Clinical Trial

— DISGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103607
• Other study ID #: DISGO
• Status: Completed
• Phase: N/A
• First received: March 27, 2017
• Last updated: March 31, 2017
• Start date: January 1, 2010
• Est. completion date: February 28, 2016

Study information

• Verified date: March 2017
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 28, 2016
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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:

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Eye Disease

Intervention

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
• 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?

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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