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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGbest corrected visual acuity (BCVA)
Using Snellen scale, decimal fraction
Time frame: within 24 weeks of surgery
value of Hertel
as measured using a Hertel exophthalmometer, to describe the degree of exophthalmos
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: within 24 weeks of surgery
N75-p100 amplitude of PVEP
Wave amplitude difference between N75-P100 peak and trough.
Time frame: 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.
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Time frame: 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.
Time frame: during the surgery