DISGO: Disappearance of Graves' Orbitopathy

Sponsor
University of Pisa (Other)
Overall Status
Completed
CT.gov ID
NCT03103607
Collaborator
(none)
99
73.9

Study Details

Study Description

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 Phase
  • Diagnostic Test: Ophthalmological evaluation
  • Diagnostic Test: Questionnaire

Study Design

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 :
Jan 1, 2010
Actual Primary Completion Date :
Dec 31, 2014
Actual Study Completion Date :
Feb 28, 2016

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pisa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marinò Michele, Ricercatore (Assistant Professor), University of Pisa
ClinicalTrials.gov Identifier:
NCT03103607
Other Study ID Numbers:
  • DISGO
First Posted:
Apr 6, 2017
Last Update Posted:
Apr 6, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2017