Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Disappearance of Graves' Orbitopathy (DISGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03103607
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Marinò Michele, 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.


Condition or disease Intervention/treatment
Thyroid Eye Disease Diagnostic Test: Ophthalmological evaluation Diagnostic Test: Questionnaire

Layout table for study information
Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Disappearance of Graves' Orbitopathy in the Long Term
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : February 28, 2016

Intervention Details:
  • 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?


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with GO
Criteria

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:


Layout table for additonal information
Responsible Party: Marinò Michele, Ricercatore (Assistant Professor), University of Pisa
ClinicalTrials.gov Identifier: NCT03103607     History of Changes
Other Study ID Numbers: DISGO
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Eye Diseases
Eye Diseases, Hereditary
Graves Ophthalmopathy
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases