Graves OphthalmopathyNCT01999790
Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy
A study testing blepharotomy and posterior approach in people with Graves Ophthalmopathy, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Graves Ophthalmopathy
- What is being tested?
- blepharotomy and posterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- pregnancy
- history of previous upper lid surgery
- myasthenia gravis
Trial locations and contacts
1 site in 1 country.
Ana Carolina A Goncalves contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, 05403-010
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Graves Ophthalmopathy
- Being tested
- blepharotomy, posterior approach
- Keywords
- upper lid, exophthalmos, grave's orbitopathy
- Medical subject headings
- Graves Ophthalmopathy, Exophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blepharotomyProcedure or surgery
upper eyelid surgery by blepharotomy
posterior approachProcedure or surgery
upper eyelid surgery by posterior approach
| Study group | Role | What they receive |
|---|---|---|
| Blepharothomy | Experimental | Patients treated with blepharotomy to correct upper lid retraction secondary to Grave's orbitopathy Receives: Procedure: blepharotomy |
| posterior approach | Experimental | Patients treated with a posterior approach to correct upper lid retraction secondary to Grave's orbitopathy Receives: Procedure: posterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical measure of the Margin Reflex distance
Assessment of the surgical correction effectiveness by measuring the eyelid lengthening
Measured: 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.
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
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan Christian Pieroni Goncalves, University of Sao Paulo
- Investigators
- Allan p Goncalves, Dr, Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999790
- Sponsor's protocol ID
- protocoloretracao
- Status last verified
- Nov 2013
- First submitted
- 17 Nov 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32280513Goncalves 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.
PubMed 29026936
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy
- ClinicalTrials.gov ID
- NCT01999790
- Acronym / sponsor ID
- protocoloretracao
- Conditions
- Graves Ophthalmopathy
- Keywords
- upper lid, exophthalmos, grave's orbitopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blepharothomy | Experimental | Procedure: blepharotomyPatients treated with blepharotomy to correct upper lid retraction secondary to Grave's orbitopathy |
| posterior approach | Experimental | Procedure: posterior approachPatients treated with a posterior approach to correct upper lid retraction secondary to Grave's orbitopathy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (3 listed)
- pregnancy
- history of previous upper lid surgery
- myasthenia gravis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blepharotomyupper eyelid surgery by blepharotomy | Procedure or surgery | Blepharothomy |
| posterior approachupper eyelid surgery by posterior approach | Procedure or surgery | posterior approach |
Primary outcome
clinical measure of the Margin Reflex distance
Time frame: 6 months
Assessment of the surgical correction effectiveness by measuring the eyelid lengthening
2 secondary outcomes
evaluation of ocular surface with OSDI (Ocular Surface Disease Index) questionnaire, clinical measures with Schirmmer test green lissamine and tear film breakup Time.
Time frame: 6 months
From the patients digital photographs,computed assisted measurements of eyelid shape and contour will be performed.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
- Derived from this study: PubMed 32280513Pereira 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.
- Derived from this study: PubMed 29026936Goncalves 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Carolina A Goncalves contact
Allan p Goncalves, Dr principal investigator
Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blepharotomy and posterior approach in people with Graves Ophthalmopathy, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Carolina A Goncalves (anamed_93@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical measure of the Margin Reflex distance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01999790, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013.