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

University of Sao Paulo

Status: Unknown

Conditions: Graves Ophthalmopathy

Treatments: Procedure: blepharotomy; Procedure: posterior approach

Study type: Interventional

Funder types: Other

Identifiers

NCT01999790

protocoloretracao

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Blepharothomy

Experimental group

Description:

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

Treatment:

Procedure: blepharotomy

posterior approach

Experimental group

Description:

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

Treatment:

Procedure: posterior approach