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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary:

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 i

Detailed Summary:

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.

Sponsor: University of Sao Paulo

Current Primary Outcome: clinical measure of the Margin Reflex distance [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• evaluation of ocular surface with OSDI (Ocular Surface Disease Index) questionnaire, clinical measures with Schirmmer test green lissamine and tear film breakup Time. [ Time Frame: 6 months ]
  OSDI (Ocular Surface Disease Index) is a questionnaire of dry eye symptoms Schirmmer test - measures tear production green lissamine test - evaluate ocular surface damage Tear film Break Up Time - evaluate tear's quality
• From the patients digital photographs,computed assisted measurements of eyelid shape and contour will be performed. [ Time Frame: 6 months ]

  with a specific software (contour) the contour and shape of the operated eyelids will be measured.

  Comparison will be made with previous photographs and of normal subjects.

Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: November 17, 2013
Date Started: March 2012
Date Completion: February 2015
Last Updated: November 25, 2013
Last Verified: November 2013