Graves Ophthalmopathy, Surgery
Conditions
Brief 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.
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.
Interventions
PROCEDUREmodified deep lateral and/or medial wall decompression
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. EUGOGO/NOSPECS grade was moderate-to-severe thyroid associate ophthalmopathy; 2. CAS≤3 score; 3. stable thyroid function for at least 6 months; 4. able and willing to participate in clinical trials and ensure regular follow-up;
Exclusion criteria
1. any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors); 2. B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.); 3. uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases 4. those who were considered by the researchers to be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| best corrected visual acuity (BCVA) | within 24 weeks of surgery | Using Snellen scale, decimal fraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the mean deviation value of visual field (VF) | 24 weeks after surgery | 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). |
| pattern standard deviation value of visual field | within 24 weeks of surgery | 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). |
| the P100 latency of pattern visual evoked potential (PVEP) | within 24 weeks of surgery | 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. |
| value of Hertel | within 24 weeks of surgery | as measured using a Hertel exophthalmometer, to describe the degree of exophthalmos |
| clinical activity score (CAS) | within 24 weeks of surgery | 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. |
| volume of adipose tissue | during the surgery | 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. |
| N75-p100 amplitude of PVEP | within 24 weeks of surgery | Wave amplitude difference between N75-P100 peak and trough. |
Countries
China
Contacts
Primary ContactHua sheng Yang, M.D,PHD
Outcome results
None listed