Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy
NCT ID: NCT01999790
Last Updated: 2013-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2012-03-31
2015-02-28
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Blepharothomy
Patients treated with blepharotomy to correct upper lid retraction secondary to Grave's orbitopathy
blepharotomy
upper eyelid surgery by blepharotomy
posterior approach
Patients treated with a posterior approach to correct upper lid retraction secondary to Grave's orbitopathy
posterior approach
upper eyelid surgery by posterior approach
Interventions
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blepharotomy
upper eyelid surgery by blepharotomy
posterior approach
upper eyelid surgery by posterior approach
Eligibility Criteria
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Inclusion Criteria
* controlled thyroid function
* absence of strabismus
* absence of other ocular pathology, such as high myopia
* understanding the protocol and according the terms
Exclusion Criteria
* history of previous upper lid surgery
* myasthenia gravis
21 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Allan Christian Pieroni Goncalves
staff
Principal Investigators
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Allan p Goncalves, Dr
Role: PRINCIPAL_INVESTIGATOR
Staff
Locations
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Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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References
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Pereira TS, Kuniyoshi CH, Leite CA, Gebrim EMMS, Monteiro MLR, Pieroni Goncalves AC. A Comparative Study of Clinical vs. Digital Exophthalmometry Measurement Methods. J Ophthalmol. 2020 Mar 23;2020:1397410. doi: 10.1155/2020/1397410. eCollection 2020.
Goncalves ACP, Nogueira T, Goncalves ACA, Silva LD, Matayoshi S, Monteiro MLR. A Comparative Study of Full-Thickness Blepharotomy Versus Transconjunctival Eyelid Lengthening in the Correction of Upper Eyelid Retraction in Graves' Orbitopathy. Aesthetic Plast Surg. 2018 Feb;42(1):215-223. doi: 10.1007/s00266-017-0978-9. Epub 2017 Oct 12.
Other Identifiers
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protocoloretracao
Identifier Type: -
Identifier Source: org_study_id