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临床试验/NCT01999790
NCT01999790Unknown不适用

Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
clinical measure of the Margin Reflex distance

研究概览

简要总结

Grave's ophthalmopathy is the most common cause of orbital disease in adults. The clinical presentation may vary between sub clinic symptoms to severe ones. The eyelid retraction is one of the most important signs of Grave's ophthalmopathy and can lead to cosmetic and functional problems.

The eyelid retraction can be found in the inflammatory stage and in the chronic disease, when it is stable. It can be described when the upper lid is contouring the superior limbus or positioned above that. This condition can lead to dry eye symptoms, exposure keratitis and cosmetic issues. The treatment can may be surgical or medical.

The medical treatment are usually based on controlling thyroid function and in the use of steroids, both are not specific for the lid retraction, but for the inflammation that is common in the disease.

In the longstanding disease, surgery is the most efficient treatment. There are several described techniques, they are based on the concept of weakening the muscles that act on lid elevation (levator and Muller Muscle).

Basically the techniques can be divided in two groups: the first with an anterior approach (with skin scar in the lid sulcus) and the second using a posterior approach (through the conjunctiva).

In the literature there is no consensus in deciding the best technique, regarding cosmetic results, incidence of complications, hypo or hypercorrection.

In this trial we propose to compare two distinct techniques that are already in clinical use. The blepharotomy uses a cutaneous approach and the other a conjunctival approach.

The patients will be divided in two randomized groups and surgical expected outcomes, cosmetics outcomes and complications occurrence will be compared.

详细描述

After a complete ophthalmic evaluation the recruited patients with inactive graves orbitopathy and upper eyelid retraction eligible for the study will be randomly separated in two groups.

The evaluation also includes a face photography in primary position of gaze, a OSDI questionnaire, a quality of life questionnaire, schirmmer test, lissamine green evaluation and eyelid position measurements.

In the first group the patients will be submitted to blepharotomy for surgical correction of their upper eyelid retraction.

In the second group the patients will be submitted to a posterior mullerectomy and gradual recession of the elevator muscle aponeurosis for surgical correction of their upper eyelid retraction.

The outcomes will be compared between the two groups after a 6 month followup.

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
None

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

  • •> 21 years old
  • •controlled thyroid function
  • •absence of strabismus
  • •absence of other ocular pathology, such as high myopia
  • •understanding the protocol and according the terms

排除标准

  • •pregnancy
  • •history of previous upper lid surgery
  • •myasthenia gravis

研究组 & 干预措施

Blepharothomy

Experimental

Patients treated with blepharotomy to correct upper lid retraction secondary to Grave's orbitopathy

干预措施: blepharotomy (Procedure)

posterior approach

Experimental

Patients treated with a posterior approach to correct upper lid retraction secondary to Grave's orbitopathy

干预措施: posterior approach (Procedure)

结局指标

主要结局

clinical measure of the Margin Reflex distance

时间窗: 6 months

Assessment of the surgical correction effectiveness by measuring the eyelid lengthening

次要结局

  • evaluation of ocular surface with OSDI (Ocular Surface Disease Index) questionnaire, clinical measures with Schirmmer test green lissamine and tear film breakup Time.(6 months)
  • From the patients digital photographs,computed assisted measurements of eyelid shape and contour will be performed.(6 months)

研究者

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

Allan Christian Pieroni Goncalves

staff

University of Sao Paulo

研究点 (1)

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