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

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ClinicalTrials.gov Identifier: NCT03278964
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Cristiane de Almeida Leite, University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Graves Ophthalmopathy Procedure: Orbital decompression Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with Graves orbitopathy will be randomly divided in two groups. One group will be submmited to orbital decompression by antro-ethmoidal technique. The other group will be treated by lateral wall technique.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants and investigators do not know which orbital decompression technique will be done until 6 months of postoperative period.
Primary Purpose: Treatment
Official Title: Comparative Morphometric, Functional and Psychosocial Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
Actual Study Start Date : February 5, 2015
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. Exophthalmos [ Time Frame: Before orbital decompression and 6 months after surgery ]
    Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography


Secondary Outcome Measures :
  1. Diplopia [ Time Frame: Before orbital decompression and 1, 3 and 6 months after surgery ]
    Evaluation by Gorman's Diplopia Table

  2. 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

  3. Volume of the extraocular muscles [ Time Frame: Before orbital decompression and 6 months after surgery ]
    Measure by orbital computerized tomography images

  4. Ocular surface evaluation [ Time Frame: Before orbital decompression and 6 months after surgery ]
    Assessed by Lysozyme Green, Break-up time, Schirmer I test

  5. Quality of life questionary Quality of life questionary [ Time Frame: Before orbital decompression and 6 months after surgery ]
    GO-QoL form



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278964


Contacts
Contact: CRISTIANE DE ALMEIDA LEITE, MD (5511)2661.6287 crisleite@yahoo.com
Contact: THAIS DE SOUSA PEREIRA, MD (5511)953502218 sthaisx@gmail.com

Locations
Brazil
University of Sao Paulo General Hospital Recruiting
São Paulo, Brazil, 05403000
Contact: CRISTIANE DE ALMEIDA LEITE, MD    (5511)981229182    crisleite@yahoo.com   
Contact: THAIS DE SOUSA PEREIRA, MD    (5511)953502218    sthaisx@gmail.com   
Principal Investigator: MARIO L RIBEIRO MONTEIRO, PHD         
Principal Investigator: ALLAN C PIERONI GONCALVES         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Chair: MARIO L RIBEIRO MONTEIRO, PHD University of Sao Paulo General Hospital

Responsible Party: Cristiane de Almeida Leite, Medical Doctor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03278964     History of Changes
Other Study ID Numbers: 39748114.0.0000.0068
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cristiane de Almeida Leite, University of Sao Paulo General Hospital:
Graves Disease
Orbital decompression
Graves Orbitopathy
Exophthalmos
Diplopia
Restrictive Strabismus

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