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临床试验/NCT03278964
NCT03278964已完成不适用

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

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Change in Ocular Motility status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants and investigators do not know which orbital decompression technique will be done until 6 months of postoperative period.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Antro-ethmoidal technique

Active Comparator

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

干预措施: Orbital decompression (Procedure)

Lateral wall technique

Experimental

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

干预措施: Orbital decompression (Procedure)

结局指标

主要结局

Change in Ocular Motility status

时间窗: 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

时间窗: Before orbital decompression and 6 months after surgery

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

次要结局

  • Digital photography evaluation(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)
  • Diplopia(Before orbital decompression and 1, 3 and 6 months after surgery)
  • Volume of the extraocular muscles(Before orbital decompression and 6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristiane de Almeida Leite

Medical Doctor

University of Sao Paulo General Hospital

研究点 (1)

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