Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy

August 11, 2019 updated by: Cristiane de Almeida Leite, University of Sao Paulo General Hospital

Comparative Morphometric, Functional and Psychosocial Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy

Randomized prospective clinical trial, aiming to compare two techniques of orbital decompression. Patients with Graves orbitopathy in the inactive phase for at least 6 months will be divided in two groups; one group will be submitted to orbital decompression by antro-ethmoidal technique; the other group will be submitted to orbital decompression by lateral wall technique. Patients will be followed up for a period of 6 months after the surgery, and will be evaluated about the effect of orbital decompression on ocular motility, proptosis, ocular surface and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Graves' orbitopathy is the most relevant non-thyroid manifestation of Graves' disease. Its clinical status varies from subclinical to severe deformities. Clinical features include palpebral retraction, exophthalmos, restrictive strabismus, chemosis, ocular surface lesions and optic neuropathy. There are two stages of the disease. There is an active phase in which the inflammatory process is present and the orbital changes evolve. The inactive phase comprises a stable clinical picture regarding the sequelae of the active phase. Orbital decompression surgery is the main treatment procedure for this inactive phase for functional and cosmetic rehabilitation purposes. In the last decades, great advances in the techniques and indication of this surgery have been observed. However, a consensus about the ideal technique does not yet exist. The most commonly used techniques are antro-ethmoidal decompression and lateral wall decompression alone or associated with other walls. The present study will be based on patients with Graves' orbitopathy diagnosis for at least 2 years and who are already in the inactive phase for at least 6 months. There are no prospective studies comparing the 2 main orbital decompression techniques through a detailed analysis of surgical outcomes from computed tomography images, digital photographic images and ocular motility examination. These informations will be collected in the preoperative and postoperative periods. The investigators will evaluate the decompressive potential of each technique calculated by the tomographic images. Participants will be followed up for a period of 6 months after the surgical procedure and the effect of decompression on ocular motility, ocular bulb positioning, ocular surface, vertical palpebral fissure, and the patient's quality of life will also be analyzed. The findings of this work will bring important contribution to the improvement of this surgical procedure of great relevance in the rehabilitation of patients with Graves' orbitopathy.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403000
        • University of Sao Paulo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Graves orbitopathy for at least 2 years
  • Clinical Activity Score (CAS) < 4 for at least 6 months
  • Agreement with the Informed Consent Form, which will be signed during the selection visit
  • Ability to come to periodic evaluations for 6 months after the orbital decompression
  • Absence of ocular abnormalities such as degenerative myopia, microphthalmia or anophthalmic cavity
  • Absence of orbital abnormalities such as previous fractures or congenital defects
  • Good collaboration for the exams
  • Euthyroidism
  • Exophthalmus ≥ 20 mm in Hertel's exophthalmometry
  • Preoperative clinical evaluation indicating absence of contraindications for a surgical procedure

Exclusion Criteria:

  • Myasthenia gravis
  • Pregnancy
  • Previous orbital, strabismus or eyelid surgery
  • Other abnormal eye conditions or symptoms that make it impossible to admit the patient to the study, according to the clinical judgment of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antro-ethmoidal technique
Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique.
Procedure: Orbital decompression
Experimental: Lateral wall technique
Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique.
Procedure: Orbital decompression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ocular Motility status
Time Frame: Before orbital decompression and 1, 3 and 6 months after surgery
Measure by prism and cover, to assess strabismus in the nine positions of gaze
Before orbital decompression and 1, 3 and 6 months after surgery
Exophthalmos
Time Frame: Before orbital decompression and 6 months after surgery
Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography
Before orbital decompression and 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diplopia
Time Frame: Before orbital decompression and 1, 3 and 6 months after surgery
Evaluation by Gorman's Diplopia Table
Before orbital decompression and 1, 3 and 6 months after surgery
Digital photography evaluation
Time Frame: Before orbital decompression and 6 months after surgery
Using digital photography, Photoshop and Image J, ductions and versions will be analyzed
Before orbital decompression and 6 months after surgery
Volume of the extraocular muscles
Time Frame: Before orbital decompression and 6 months after surgery
Measure by orbital computerized tomography images
Before orbital decompression and 6 months after surgery
Ocular surface evaluation
Time Frame: Before orbital decompression and 6 months after surgery
Assessed by Lysozyme Green, Break-up time, Schirmer I test
Before orbital decompression and 6 months after surgery
Quality of life questionary Quality of life questionary
Time Frame: Before orbital decompression and 6 months after surgery
GO-QoL form
Before orbital decompression and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Chair: MARIO L RIBEIRO MONTEIRO, PHD, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2015

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 11, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39748114.0.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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