Graves OphthalmopathyNCT06588764
Modified Orbital Decompression in the Treatment of Moderate-to-severe Grave's Ophthalmopathy
A study testing modified deep lateral and/or medial wall decompression in people with Graves Ophthalmopathy and Surgery, run by Sun Yat-sen University at 1 site in China.
Trial summary
To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Graves Ophthalmopathy, Surgery
- What is being tested?
- modified deep lateral and/or medial wall decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Jan 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EUGOGO/NOSPECS grade was moderate-to-severe thyroid associate ophthalmopathy;
- CAS≤3 score;
- stable thyroid function for at least 6 months;
- able and willing to participate in clinical trials and ensure regular follow-up;
Who cannot join
- any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
- B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
- uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases
- those who were considered by the researchers to be excluded
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Huasheng Yang, M.D, PHD, +8613602721743, yanghs64@126.com
About this study
Official title: Modified Deep Lateral Wall Decompression and/or Deep Medial Wall Decompression for Moderate-to-severe Grave's Ophthalmopathy: a Prospective Study
To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.
Read the detailed description
The purpose of the study is to evaluate the effectiveness and complications of modified deep lateral wall decompression and medial wall decompression, in order to develop a standardized technical approach to the treatment of Moderate-to-severe Grave's Ophthalmopathy.
- Conditions
- Graves Ophthalmopathy, Surgery
- Being tested
- modified deep lateral and/or medial wall decompression
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified deep lateral and/or medial wall decompressionProcedure or surgery
Modified deep lateral orbital wall decompression is based on traditional outer wall decompression with combined abrasion of the deep outer orbital wall (including the greater pterygoid wing) to achieve adequate enlargement of the orbital cavity.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Modified deep lateral and/or medial wall decompression in Moderate-to-severe Graves' Orbitopathy Receives: Procedure: modified deep lateral and/or medial wall decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity (BCVA)
Using Snellen scale, decimal fraction
Measured: within 24 weeks of surgery
Secondary outcomes (7)
value of Hertel
as measured using a Hertel exophthalmometer, to describe the degree of exophthalmos
Measured: within 24 weeks of surgery
the mean deviation value of visual field (VF)
The mean deviation (MD) gives an overall value of the total amount of visual field loss, with normal values typically within 0dB to -2dB. The mean deviation value of visual field (VF) was examined by HFA (Humphrey II, Carl-Zeiss, Dublin, CA).
Measured: 24 weeks after surgery
pattern standard deviation value of visual field
The pattern standard deviation (PSD) can filter out the decrease in visual acuity caused by turbidity of the dioptric interstitial. The pattern standard deviation (PSD) was examined by HFA (Humphrey II, Carl-Zeiss, Dublin, CA).
Measured: within 24 weeks of surgery
the P100 latency of pattern visual evoked potential (PVEP)
The visual stimulus was a pattern reversal checkerboard displayed on a black and white monitor placed 105 cm from the patient. The wave latency of P100 was recorded.
Measured: within 24 weeks of surgery
N75-p100 amplitude of PVEP
Wave amplitude difference between N75-P100 peak and trough.
Measured: within 24 weeks of surgery
clinical activity score (CAS)
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/ Graves' Ophthalmopathy or Orbitopathy (TED/GO); 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore "equivocal" redness); 6. Chemosis; 7. Inflammation of caruncle or plica.
Measured: within 24 weeks of surgery
volume of adipose tissue
Prolapsing extraconal and intraconal orbital fat were resected from the orbital margin deep into the intraconal apex. The desired volume of adipose tissue was measured intraoperatively using 5 or 10 cc syringe.
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huasheng Yang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588764
- Sponsor's protocol ID
- yanghs20240821
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Deep Lateral Wall Decompression and/or Deep Medial Wall Decompression for Moderate-to-severe Grave's Ophthalmopathy: a Prospective Study
- ClinicalTrials.gov ID
- NCT06588764
- Acronym / sponsor ID
- yanghs20240821
- Conditions
- Graves Ophthalmopathy, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.
Detailed description
The purpose of the study is to evaluate the effectiveness and complications of modified deep lateral wall decompression and medial wall decompression, in order to develop a standardized technical approach to the treatment of Moderate-to-severe Grave's Ophthalmopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: modified deep lateral and/or medial wall decompressionModified deep lateral and/or medial wall decompression in Moderate-to-severe Graves' Orbitopathy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- EUGOGO/NOSPECS grade was moderate-to-severe thyroid associate ophthalmopathy;
- CAS≤3 score;
- stable thyroid function for at least 6 months;
- able and willing to participate in clinical trials and ensure regular follow-up;
Key exclusion criteria (4 listed)
- any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
- B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
- uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases
- those who were considered by the researchers to be excluded
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 |
|---|---|---|
| modified deep lateral and/or medial wall decompressionModified deep lateral orbital wall decompression is based on traditional outer wall decompression with combined abrasion of the deep outer orbital wall (including the greater pterygoid wing) to achieve adequate enlargement of the orbital cavity. | Procedure or surgery | Study group |
Primary outcome
best corrected visual acuity (BCVA)
Time frame: within 24 weeks of surgery
Using Snellen scale, decimal fraction
7 secondary outcomes
value of Hertel
Time frame: within 24 weeks of surgery
the mean deviation value of visual field (VF)
Time frame: 24 weeks after surgery
pattern standard deviation value of visual field
Time frame: within 24 weeks of surgery
the P100 latency of pattern visual evoked potential (PVEP)
Time frame: within 24 weeks of surgery
N75-p100 amplitude of PVEP
Time frame: within 24 weeks of surgery
clinical activity score (CAS)
Time frame: within 24 weeks of surgery
volume of adipose tissue
Time frame: during the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified deep lateral and/or medial wall decompression in people with Graves Ophthalmopathy and Surgery, run by Sun Yat-sen University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 China. 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 Hua sheng Yang, M.D,PHD (+8620-87331539, yanghs64@162.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best corrected visual acuity (BCVA) (time frame: within 24 weeks of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.