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

Graves Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01999790
• Other study ID #: protocoloretracao
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2013
• Last updated: November 25, 2013
• Start date: March 2012
• Est. completion date: February 2015

Study information

• Verified date: November 2013
• Source: University of Sao Paulo
• Contact: Ana Carolina A Goncalves
• Email: anamed_93[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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 in two randomized groups and surgical expected outcomes, cosmetics outcomes and complications occurrence will be compared.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy

Intervention

Procedure:
• blepharotomy
upper eyelid surgery by blepharotomy
• posterior approach
upper eyelid surgery by posterior approach

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - FMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical measure of the Margin Reflex distance	Assessment of the surgical correction effectiveness by measuring the eyelid lengthening	6 months	Yes
Secondary	evaluation of ocular surface with OSDI (Ocular Surface Disease Index) questionnaire, clinical measures with Schirmmer test green lissamine and tear film breakup Time.	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	6 months	Yes
Secondary	From the patients digital photographs,computed assisted measurements of eyelid shape and contour will be performed.	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.	6 months	Yes