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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01999790
Recruitment Status : Unknown
Verified November 2013 by Allan Christian Pieroni Goncalves, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 3, 2013
Last Update Posted : December 3, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Graves Ophthalmopathy Procedure: blepharotomy Procedure: posterior approach

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy
Study Start Date : March 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Blepharothomy
Patients treated with blepharotomy to correct upper lid retraction secondary to Grave's orbitopathy
Procedure: blepharotomy
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

Outcome Measures

Primary Outcome Measures :
  1. clinical measure of the Margin Reflex distance [ Time Frame: 6 months ]
    Assessment of the surgical correction effectiveness by measuring the eyelid lengthening

Secondary Outcome Measures :
  1. 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

  2. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999790

Contact: Ana Carolina A Goncalves anamed_93@yahoo.com.br

Hospital das Clinicas - FMUSP Recruiting
São Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Allan p Goncalves, Dr Staff
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allan Christian Pieroni Goncalves, staff, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01999790     History of Changes
Other Study ID Numbers: protocoloretracao
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: November 2013

Keywords provided by Allan Christian Pieroni Goncalves, University of Sao Paulo:
upper lid
grave's orbitopathy

Additional relevant MeSH terms:
Graves Ophthalmopathy
Graves Disease
Eye Diseases
Eye Diseases, Hereditary
Orbital Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases