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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01999790
Enrollment
40
Registered
2013-12-03
Start date
2012-03-31
Completion date
2015-02-28
Last updated
2013-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves Ophthalmopathy

Keywords

upper lid, exophthalmos, grave's orbitopathy

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.

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.

Interventions

PROCEDUREblepharotomy

upper eyelid surgery by blepharotomy

upper eyelid surgery by posterior approach

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
clinical measure of the Margin Reflex distance6 monthsAssessment of the surgical correction effectiveness by measuring the eyelid lengthening

Secondary

MeasureTime frameDescription
evaluation of ocular surface with OSDI (Ocular Surface Disease Index) questionnaire, clinical measures with Schirmmer test green lissamine and tear film breakup Time.6 monthsOSDI (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.6 monthswith 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.

Countries

Brazil

Contacts

Primary ContactAna Carolina A Goncalves
anamed_93@yahoo.com.br

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026