Graves OphthalmopathyNCT03278964
Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
A study testing Orbital decompression in people with Graves Ophthalmopathy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Randomized prospective clinical trial, aiming to compare two techniques of orbital decompression. Patients with Graves orbitopathy in the inactive phase for at least 6 months will be divided in two groups; one group will be submitted to orbital decompression by antro-ethmoidal technique; the other group will be… 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?
- Orbital decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Feb 2015to 31 Jan 2019
- 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
- Diagnosis of Graves orbitopathy for at least 2 years
- Clinical Activity Score (CAS) < 4 for at least 6 months
- Agreement with the Informed Consent Form, which will be signed during the selection visit
- Ability to come to periodic evaluations for 6 months after the orbital decompression
- Absence of ocular abnormalities such as degenerative myopia, microphthalmia or anophthalmic cavity
- Absence of orbital abnormalities such as previous fractures or congenital defects
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- Good collaboration for the exams
- Euthyroidism
- Exophthalmus ≥ 20 mm in Hertel's exophthalmometry
- Preoperative clinical evaluation indicating absence of contraindications for a surgical procedure
Who cannot join
- Myasthenia gravis
- Pregnancy
- Previous orbital, strabismus or eyelid surgery
- Other abnormal eye conditions or symptoms that make it impossible to admit the patient to the study, according to the clinical judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Morphometric, Functional and Psychosocial Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
Randomized prospective clinical trial, aiming to compare two techniques of orbital decompression. Patients with Graves orbitopathy in the inactive phase for at least 6 months will be divided in two groups; one group will be submitted to orbital decompression by antro-ethmoidal technique; the other group will be submitted to orbital decompression by lateral wall technique. Patients will be followed up for a period of 6 months after the surgery, and will be evaluated about the effect of orbital decompression on ocular motility, proptosis, ocular surface and quality of life.
Read the detailed description
Graves' orbitopathy is the most relevant non-thyroid manifestation of Graves' disease. Its clinical status varies from subclinical to severe deformities. Clinical features include palpebral retraction, exophthalmos, restrictive strabismus, chemosis, ocular surface lesions and optic neuropathy. There are two stages of the disease. There is an active phase in which the inflammatory process is present and the orbital changes evolve. The inactive phase comprises a stable clinical picture regarding the sequelae of the active phase. Orbital decompression surgery is the main treatment procedure for this inactive phase for functional and cosmetic rehabilitation purposes. In the last decades, great advances in the techniques and indication of this surgery have been observed. However, a consensus about the ideal technique does not yet exist. The most commonly used techniques are antro-ethmoidal decompression and lateral wall decompression alone or associated with other walls. The present study will be based on patients with Graves' orbitopathy diagnosis for at least 2 years and who are already in the inactive phase for at least 6 months. There are no prospective studies comparing the 2 main orbital decompression techniques through a detailed analysis of surgical outcomes from computed tomography images, digital photographic images and ocular motility examination. These informations will be collected in the preoperative and postoperative periods. The investigators will evaluate the decompressive potential of each technique calculated by the tomographic images. Participants will be followed up for a period of 6 months after the surgical procedure and the effect of decompression on ocular motility, ocular bulb positioning, ocular surface, vertical palpebral fissure, and the patient's quality of life will also be analyzed. The findings of this work will bring important contribution to the improvement of this surgical procedure of great relevance in the rehabilitation of patients with Graves' orbitopathy.
- Conditions
- Graves Ophthalmopathy
- Being tested
- Orbital decompression
- Keywords
- Graves Disease, Orbital decompression, Graves Orbitopathy, Exophthalmos, Diplopia, Restrictive Strabismus
- Medical subject headings
- Graves Ophthalmopathy, Graves Disease, Exophthalmos, Diplopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbital decompressionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Antro-ethmoidal technique | Active comparator | Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique. Receives: Procedure: Orbital decompression |
| Lateral wall technique | Experimental | Patients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique. Receives: Procedure: Orbital decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Motility status
Measure by prism and cover, to assess strabismus in the nine positions of gaze
Measured: Before orbital decompression and 1, 3 and 6 months after surgery
Exophthalmos
Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography
Measured: Before orbital decompression and 6 months after surgery
Secondary outcomes (5)
Diplopia
Evaluation by Gorman's Diplopia Table
Measured: Before orbital decompression and 1, 3 and 6 months after surgery
Digital photography evaluation
Using digital photography, Photoshop and Image J, ductions and versions will be analyzed
Measured: Before orbital decompression and 6 months after surgery
Volume of the extraocular muscles
Measure by orbital computerized tomography images
Measured: Before orbital decompression and 6 months after surgery
Ocular surface evaluation
Assessed by Lysozyme Green, Break-up time, Schirmer I test
Measured: Before orbital decompression and 6 months after surgery
Quality of life questionary Quality of life questionary
GO-QoL form
Measured: Before orbital decompression and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start5 Feb 2015
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Model description
- Patients with Graves orbitopathy will be randomly divided in two groups. One group will be submmited to orbital decompression by antro-ethmoidal technique. The other group will be treated by lateral wall technique.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane de Almeida Leite, University of Sao Paulo General Hospital
- Investigators
- MARIO L RIBEIRO MONTEIRO, PHD, Study chair, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278964
- Sponsor's protocol ID
- 39748114.0.0000.0068
- Status last verified
- Aug 2019
- First submitted
- 4 Sep 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leite CA, Pereira TS, Chiang J, Moritz RB, Goncalves ACP, Monteiro MLR. Ocular motility changes after inferomedial wall and balanced medial plus lateral wall orbital decompression in Graves' orbitopathy: a randomized prospective comparative study. Clinics (Sao Paulo). 2021 Apr 9;76:e2592. doi: 10.6061/clinics/2021/e2592. eCollection 2021.
PubMed 33852655Leite CA, Pereira TS, Chiang J, Pieroni Goncalves AC, Monteiro MLR. Evaluation of Ocular Versions in Graves' Orbitopathy: Correlation between the Qualitative Clinical Method and the Quantitative Photographic Method. J Ophthalmol. 2020 Jul 31;2020:9758153. doi: 10.1155/2020/9758153. eCollection 2020.
PubMed 32832143
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Morphometric, Functional and Psychosocial Analysis Between the Results of Two Surgical Techniques of Orbital Decompression in Patients With Graves Orbitopathy
- ClinicalTrials.gov ID
- NCT03278964
- Acronym / sponsor ID
- 39748114.0.0000.0068
- Conditions
- Graves Ophthalmopathy
- Keywords
- Graves Disease, Orbital decompression, Graves Orbitopathy, Exophthalmos, Diplopia, Restrictive Strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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.
Randomized prospective clinical trial, aiming to compare two techniques of orbital decompression. Patients with Graves orbitopathy in the inactive phase for at least 6 months will be divided in two groups; one group will be submitted to orbital decompression by antro-ethmoidal technique; the other group will be submitted to orbital decompression by lateral wall technique. Patients will be followed up for a period of 6 months after the surgery, and will be evaluated about the effect of orbital decompression on ocular motility, proptosis, ocular surface and quality of life.
Detailed description
Graves' orbitopathy is the most relevant non-thyroid manifestation of Graves' disease. Its clinical status varies from subclinical to severe deformities. Clinical features include palpebral retraction, exophthalmos, restrictive strabismus, chemosis, ocular surface lesions and optic neuropathy. There are two stages of the disease. There is an active phase in which the inflammatory process is present and the orbital changes evolve. The inactive phase comprises a stable clinical picture regarding the sequelae of the active phase. Orbital decompression surgery is the main treatment procedure for this inactive phase for functional and cosmetic rehabilitation purposes. In the last decades, great advances in the techniques and indication of this surgery have been observed. However, a consensus about the ideal technique does not yet exist. The most commonly used techniques are antro-ethmoidal decompression and lateral wall decompression alone or associated with other walls. The present study will be based on patients with Graves' orbitopathy diagnosis for at least 2 years and who are already in the inactive phase for at least 6 months. There are no prospective studies comparing the 2 main orbital decompression techniques through a detailed analysis of surgical outcomes from computed tomography images, digital photographic images and ocular motility examination. These informations will be collected in the preoperative and postoperative periods. The investigators will evaluate the decompressive potential of each technique calculated by the tomographic images. Participants will be followed up for a period of 6 months after the surgical procedure and the effect of decompression on ocular motility, ocular bulb positioning, ocular surface, vertical palpebral fissure, and the patient's quality of life will also be analyzed. The findings of this work will bring important contribution to the improvement of this surgical procedure of great relevance in the rehabilitation of patients with Graves' orbitopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with Graves orbitopathy will be randomly divided in two groups. One group will be submmited to orbital decompression by antro-ethmoidal technique. The other group will be treated by lateral wall technique.
| Arm | Type | Receives |
|---|---|---|
| Antro-ethmoidal technique | Active comparator | Procedure: Orbital decompressionPatients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by antro-ethmoidal technique. |
| Lateral wall technique | Experimental | Procedure: Orbital decompressionPatients in the inactive phase of Graves orbitopathy will be submitted to orbital decompression by lateral wall technique. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of Graves orbitopathy for at least 2 years
- Clinical Activity Score (CAS) < 4 for at least 6 months
- Agreement with the Informed Consent Form, which will be signed during the selection visit
- Ability to come to periodic evaluations for 6 months after the orbital decompression
- Absence of ocular abnormalities such as degenerative myopia, microphthalmia or anophthalmic cavity
Key exclusion criteria (4 listed)
- Myasthenia gravis
- Pregnancy
- Previous orbital, strabismus or eyelid surgery
- Other abnormal eye conditions or symptoms that make it impossible to admit the patient to the study, according to the clinical judgment of the investigator.
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 |
|---|---|---|
| Orbital decompression | Procedure or surgery | Antro-ethmoidal technique, Lateral wall technique |
Primary outcome
Change in Ocular Motility status
Time frame: Before orbital decompression and 1, 3 and 6 months after surgery
Measure by prism and cover, to assess strabismus in the nine positions of gaze
Exophthalmos
Time frame: Before orbital decompression and 6 months after surgery
Exophthalmos will be measured by Hertel's exophthalmometer and orbital computerized tomography
5 secondary outcomes
Diplopia
Time frame: Before orbital decompression and 1, 3 and 6 months after surgery
Digital photography evaluation
Time frame: Before orbital decompression and 6 months after surgery
Volume of the extraocular muscles
Time frame: Before orbital decompression and 6 months after surgery
Ocular surface evaluation
Time frame: Before orbital decompression and 6 months after surgery
Quality of life questionary Quality of life questionary
Time frame: Before orbital decompression and 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 33852655Leite CA, Pereira TS, Chiang J, Moritz RB, Goncalves ACP, Monteiro MLR. Ocular motility changes after inferomedial wall and balanced medial plus lateral wall orbital decompression in Graves' orbitopathy: a randomized prospective comparative study. Clinics (Sao Paulo). 2021 Apr 9;76:e2592. doi: 10.6061/clinics/2021/e2592. eCollection 2021.
- Derived from this study: PubMed 32832143Leite CA, Pereira TS, Chiang J, Pieroni Goncalves AC, Monteiro MLR. Evaluation of Ocular Versions in Graves' Orbitopathy: Correlation between the Qualitative Clinical Method and the Quantitative Photographic Method. J Ophthalmol. 2020 Jul 31;2020:9758153. doi: 10.1155/2020/9758153. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
MARIO L RIBEIRO MONTEIRO, PHD study chair
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orbital decompression in people with Graves Ophthalmopathy, run by University of Sao Paulo General Hospital 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 10 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ocular Motility status (time frame: Before orbital decompression and 1, 3 and 6 months after surgery). The study lists 2 primary outcomes in all. 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 NCT03278964, 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 13 Aug 2019.