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

NCT01999790 | Unknown

• 1 other identifier: protocoloretracao
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Graves Ophthalmopathy

Keywords

upper lid; exophthalmos; grave's orbitopathy

Outcome Measures

Primary Outcomes (1)

• clinical measure of the Margin Reflex distance

  Assessment of the surgical correction effectiveness by measuring the eyelid lengthening

  6 months

Secondary Outcomes (2)

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

  6 months

• From the patients digital photographs,computed assisted measurements of eyelid shape and contour will be performed.

  6 months

Study Arms (2)

Blepharothomy

EXPERIMENTAL

Patients treated with blepharotomy to correct upper lid retraction secondary to Grave's orbitopathy

Procedure: blepharotomy

posterior approach

EXPERIMENTAL

Patients treated with a posterior approach to correct upper lid retraction secondary to Grave's orbitopathy

Procedure: posterior approach

Interventions

blepharotomy PROCEDURE

upper eyelid surgery by blepharotomy

Blepharothomy

posterior approach PROCEDURE

upper eyelid surgery by posterior approach

posterior approach

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• pregnancy
• history of previous upper lid surgery
• myasthenia gravis

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 32280513 DERIVED

• 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.

  PMID: 29026936 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy; Exophthalmos

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Allan p Goncalves, Dr

  Staff

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Carolina A Goncalves

CONTACT

anamed_93@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: staff

Study Record Dates

• First Submitted: November 17, 2013
• First Posted: December 3, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: December 3, 2013

Record last verified: 2013-11

Locations

BR (1)