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OpenTrials
Completed

NCT Number: NCT03103607

Disappearance of Graves' Orbitopathy

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.

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Key information

Conditions

Thyroid Eye Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ophthalmological evaluation

Diagnostic Test

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

Diagnostic Test

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?

Primary outcomes

  1. Disappearance of GO

    Time frame: 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 outcomes

  1. Objective disappearance of GO

    Time frame: 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

  2. Subjective disappearance of GO

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: DISGO

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Apr 6, 2017
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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