Modified Orbital Decompression in the Treatment of Moderate-to-severe Grave's Ophthalmopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSun Yat-sen University
About this trial
To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
modified deep lateral and/or medial wall decompression
Procedure/SurgeryModified 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
best corrected visual acuity (BCVA)
Using Snellen scale, decimal fraction
Time frame
within 24 weeks of surgerySecondary outcomes
1
value of Hertel
as measured using a Hertel exophthalmometer, to describe the degree of exophthalmos
Time frame
within 24 weeks of surgery2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov