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

Primary Purpose

Graves Ophthalmopathy

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
blepharotomy
posterior approach
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves Ophthalmopathy focused on measuring upper lid, exophthalmos, grave's orbitopathy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clinicas - FMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Blepharothomy

posterior approach

Arm Description

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

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

Outcomes

Primary Outcome Measures

clinical measure of the Margin Reflex distance
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.
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.
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.

Full Information

First Posted
November 17, 2013
Last Updated
November 25, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01999790
Brief Title
Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy
Official Title
Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Ophthalmopathy
Keywords
upper lid, exophthalmos, grave's orbitopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blepharothomy
Arm Type
Experimental
Arm Description
Patients treated with blepharotomy to correct upper lid retraction secondary to Grave's orbitopathy
Arm Title
posterior approach
Arm Type
Experimental
Arm Description
Patients treated with a posterior approach to correct upper lid retraction secondary to Grave's orbitopathy
Intervention Type
Procedure
Intervention Name(s)
blepharotomy
Intervention Description
upper eyelid surgery by blepharotomy
Intervention Type
Procedure
Intervention Name(s)
posterior approach
Intervention Description
upper eyelid surgery by posterior approach
Primary Outcome Measure Information:
Title
clinical measure of the Margin Reflex distance
Description
Assessment of the surgical correction effectiveness by measuring the eyelid lengthening
Time Frame
6 months
Secondary Outcome Measure Information:
Title
evaluation of ocular surface with OSDI (Ocular Surface Disease Index) questionnaire, clinical measures with Schirmmer test green lissamine and tear film breakup Time.
Description
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
Time Frame
6 months
Title
From the patients digital photographs,computed assisted measurements of eyelid shape and contour will be performed.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Carolina A Goncalves
Email
anamed_93@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan p Goncalves, Dr
Organizational Affiliation
Staff
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas - FMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
32280513
Citation
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.
Results Reference
derived
PubMed Identifier
29026936
Citation
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.
Results Reference
derived

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

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