Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy|
- clinical measure of the Margin Reflex distance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Assessment of the surgical correction effectiveness by measuring the eyelid lengthening
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients treated with blepharotomy to correct upper lid retraction secondary to Grave's orbitopathy
upper eyelid surgery by blepharotomy
Experimental: posterior approach
Patients treated with a posterior approach to correct upper lid retraction secondary to Grave's orbitopathy
Procedure: posterior approach
upper eyelid surgery by posterior approach
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01999790
|Contact: Ana Carolina A Goncalvesfirstname.lastname@example.org|
|Hospital das Clinicas - FMUSP||Recruiting|
|São Paulo, SP, Brazil, 05403-010|
|Principal Investigator:||Allan p Goncalves, Dr||Staff|