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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Allan Christian Pieroni Goncalves, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01999790
First received: November 17, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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 Intervention
Graves Ophthalmopathy
Procedure: blepharotomy
Procedure: posterior approach

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 40
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999790

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

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

No publications provided

Responsible Party: Allan Christian Pieroni Goncalves, staff, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01999790     History of Changes
Other Study ID Numbers: protocoloretracao
Study First Received: November 17, 2013
Last Updated: November 25, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
upper lid
exophthalmos
grave's orbitopathy

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

ClinicalTrials.gov processed this record on September 18, 2014