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

Primary Purpose

Graves Ophthalmopathy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Orbital decompression
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves Ophthalmopathy focused on measuring Graves Disease, Orbital decompression, Graves Orbitopathy, Exophthalmos, Diplopia, Restrictive Strabismus

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Antro-ethmoidal technique

Lateral wall technique

Arm Description

Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique.

Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique.

Outcomes

Primary Outcome Measures

Change in Ocular Motility status
Measure by prism and cover, to assess strabismus in the nine positions of gaze
Exophthalmos
Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography

Secondary Outcome Measures

Diplopia
Evaluation by Gorman's Diplopia Table
Digital photography evaluation
Using digital photography, Photoshop and Image J, ductions and versions will be analyzed
Volume of the extraocular muscles
Measure by orbital computerized tomography images
Ocular surface evaluation
Assessed by Lysozyme Green, Break-up time, Schirmer I test
Quality of life questionary Quality of life questionary
GO-QoL form

Full Information

First Posted
September 4, 2017
Last Updated
August 11, 2019
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03278964
Brief Title
Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
Official Title
Comparative Morphometric, Functional and Psychosocial Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 5, 2015 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Ophthalmopathy
Keywords
Graves Disease, Orbital decompression, Graves Orbitopathy, Exophthalmos, Diplopia, Restrictive Strabismus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants and investigators do not know which orbital decompression technique will be done until 6 months of postoperative period.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antro-ethmoidal technique
Arm Type
Active Comparator
Arm Description
Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique.
Arm Title
Lateral wall technique
Arm Type
Experimental
Arm Description
Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique.
Intervention Type
Procedure
Intervention Name(s)
Orbital decompression
Primary Outcome Measure Information:
Title
Change in Ocular Motility status
Description
Measure by prism and cover, to assess strabismus in the nine positions of gaze
Time Frame
Before orbital decompression and 1, 3 and 6 months after surgery
Title
Exophthalmos
Description
Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography
Time Frame
Before orbital decompression and 6 months after surgery
Secondary Outcome Measure Information:
Title
Diplopia
Description
Evaluation by Gorman's Diplopia Table
Time Frame
Before orbital decompression and 1, 3 and 6 months after surgery
Title
Digital photography evaluation
Description
Using digital photography, Photoshop and Image J, ductions and versions will be analyzed
Time Frame
Before orbital decompression and 6 months after surgery
Title
Volume of the extraocular muscles
Description
Measure by orbital computerized tomography images
Time Frame
Before orbital decompression and 6 months after surgery
Title
Ocular surface evaluation
Description
Assessed by Lysozyme Green, Break-up time, Schirmer I test
Time Frame
Before orbital decompression and 6 months after surgery
Title
Quality of life questionary Quality of life questionary
Description
GO-QoL form
Time Frame
Before orbital decompression and 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIO L RIBEIRO MONTEIRO, PHD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33852655
Citation
Leite CA, Pereira TS, Chiang J, Moritz RB, Goncalves ACP, Monteiro MLR. Ocular motility changes after inferomedial wall and balanced medial plus lateral wall orbital decompression in Graves' orbitopathy: a randomized prospective comparative study. Clinics (Sao Paulo). 2021 Apr 9;76:e2592. doi: 10.6061/clinics/2021/e2592. eCollection 2021.
Results Reference
derived
PubMed Identifier
32832143
Citation
Leite CA, Pereira TS, Chiang J, Pieroni Goncalves AC, Monteiro MLR. Evaluation of Ocular Versions in Graves' Orbitopathy: Correlation between the Qualitative Clinical Method and the Quantitative Photographic Method. J Ophthalmol. 2020 Jul 31;2020:9758153. doi: 10.1155/2020/9758153. eCollection 2020.
Results Reference
derived

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

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