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To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Modified deep lateral and/or medial wall decompression in Moderate-to-severe Graves' Orbitopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified deep lateral and/or medial wall decompression | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| best corrected visual acuity (BCVA) | Using Snellen scale, decimal fraction | within 24 weeks of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| value of Hertel | as measured using a Hertel exophthalmometer, to describe the degree of exophthalmos | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua sheng Yang, M.D,PHD | Contact | +8620-87331539 | yanghs64@162.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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|
| 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). | 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. | within 24 weeks of surgery |
| N75-p100 amplitude of PVEP | Wave amplitude difference between N75-P100 peak and trough. | 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. | 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. | during the surgery |
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |