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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03278964

Collaborator

(none)

Enrollment

Location

Arms

47.8

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Graves Ophthalmopathy	Procedure: Orbital decompression	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

42 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.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 :

Feb 5, 2015

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Ocular Motility status [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
Exophthalmos [Before orbital decompression and 6 months after surgery]
Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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.