Actively Recruiting
Modified Deep Lateral Wall Decompression and/or Deep Medial Wall Decompression for Moderate-to-severe Grave's Ophthalmopathy: a Prospective Study
Led by Sun Yat-sen University · Updated on 2024-09-19
50
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of modified deep lateral wall decompression and/or medial wall decompression surgeries for adults with moderate-to-severe Graves' Ophthalmopathy. This study aims to develop a standard surgical approach to better treat this eye condition by comparing these decompression techniques. The trial is a prospective, interventional study sponsored by Sun Yat-sen University. The study involves a surgical procedure called modified deep lateral orbital wall decompression, which enhances the traditional outer wall decompression by including abrasion of the deep outer orbital wall. This allows for greater enlargement of the orbital cavity. Participants will receive this modified decompression surgery to assess its outcomes and possible complications. Participants will be monitored for up to 24 weeks after surgery, with assessments including best corrected visual acuity, measurements of eye protrusion (Hertel value), visual field tests, visual evoked potentials, and clinical activity scores. During surgery, the volume of adipose tissue will also be evaluated. Regular follow-ups are required to track safety and effectiveness throughout the study period.
CONDITIONS
Brief Title
Modified Orbital Decompression in the Treatment of Moderate-to-severe Grave's Ophthalmopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate-to-severe thyroid-associated ophthalmopathy according to EUGOGO/NOSPECS grade
- Clinical activity score (CAS) of 3 or less
- Stable thyroid function for at least 6 months
- Willing and able to participate in clinical trials and attend regular follow-up visits
You will not qualify if you...
- Uncontrolled severe mental, neurological, cardiovascular, respiratory, or other systemic diseases
- Malignant tumors
- Other causes of eye bulging found by ultrasound, CT, or MRI (such as intraorbital mass, inflammatory pseudotumor, neurofibroma)
- Eye diseases including uveitis, glaucoma, high myopia, or diabetic retinopathy
- Any other conditions that researchers consider grounds for exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks
Participants undergo modified deep lateral and/or medial wall orbital decompression surgery followed by immediate post-operative care to monitor recovery and surgical outcomes.
Regular visits during 24 weeks after surgery
Trial Site Locations
Total: 1 location
1
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Hua sheng Yang, M.D,PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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