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

NCT03278964 | Completed DMC

• 1 other identifier: 39748114.0.0000.0068
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Graves Ophthalmopathy

Keywords

Graves Disease; Orbital decompression; Graves Orbitopathy; Exophthalmos; Diplopia; Restrictive Strabismus

Outcome Measures

Primary Outcomes (2)

• Change in Ocular Motility status

  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

  Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography

  Before orbital decompression and 6 months after surgery

Secondary Outcomes (5)

• Diplopia

  Before orbital decompression and 1, 3 and 6 months after surgery

• Digital photography evaluation

  Before orbital decompression and 6 months after surgery

• Volume of the extraocular muscles

  Before orbital decompression and 6 months after surgery

• Ocular surface evaluation

  Before orbital decompression and 6 months after surgery

• Quality of life questionary Quality of life questionary

  Before orbital decompression and 6 months after surgery

Study Arms (2)

Antro-ethmoidal technique

ACTIVE COMPARATOR

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

Procedure: Orbital decompression

Lateral wall technique

EXPERIMENTAL

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

Procedure: Orbital decompression

Interventions

Orbital decompression PROCEDURE

Antro-ethmoidal technique; Lateral wall technique

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, 05403000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 33852655 DERIVED

• 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.

  PMID: 32832143 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy; Graves Disease; Exophthalmos; Diplopia

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MARIO L RIBEIRO MONTEIRO, PHD

  University of Sao Paulo General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and investigators do not know which orbital decompression technique will be done until 6 months of postoperative period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 12, 2017
• Study Start: February 5, 2015
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

BR (1)