Clinical Trials Logo

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.


Clinical Trial 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

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


Related Conditions & MeSH terms


NCT number NCT01999790
Study type Interventional
Source University of Sao Paulo
Contact Ana Carolina A Goncalves
Email anamed_93@yahoo.com.br
Status Recruiting
Phase N/A
Start date March 2012
Completion date February 2015

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05532072 - Rapamycin Plus Methylprednisolone Versus Methylprednisolone Alone in Active, Moderate-to-severe Graves' Orbitopathy. Early Phase 1
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Recruiting NCT05678374 - Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease
Recruiting NCT03708627 - Bimatoprost as a Treatment for Graves' Orbitopathy Early Phase 1
Not yet recruiting NCT06413043 - Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy N/A
Withdrawn NCT01379196 - Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy Phase 1/Phase 2
Recruiting NCT06275373 - The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
Recruiting NCT06226545 - A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease Phase 2
Recruiting NCT05126147 - Hydroxychloroquine in Mild Graves' Orbitopathy Phase 4
Recruiting NCT03066076 - Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy Phase 3
Active, not recruiting NCT03122847 - Glucocorticoids and Bone in Graves' Ophthalmopathy
Terminated NCT01893450 - Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment N/A
Completed NCT00348413 - Thyroid Treatment Trial N/A
Completed NCT03498417 - Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy
Not yet recruiting NCT04598815 - Sirolimus for Graves' Orbitopathy (GO) Phase 2
Terminated NCT01114503 - A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease Phase 2
Completed NCT05775185 - Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy
Completed NCT05793359 - Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves' Orbitopathy
Recruiting NCT02203682 - Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy Phase 2