The Therapeutic Effect of Dysthyroid Optic Neuropathy
- Conditions
- Thyroid Eye Disease
- Interventions
- Procedure: Orbital decompression combined with MPT
- Registration Number
- NCT04096612
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
Thyroid associated ophthalmopathy (TAO) is a common autoimmune disorder. The pathogenesis of TAO is unclear, and studies found that T cell, B cell and monocytes, macrophages and mast cells are located in the orbital tissue of TAO. Dysthyroid optic neuropathy (DON) is the most serious complication of TAO, which can cause blurred vision, color vision and vision function damage, and affects the quality of life. Investigation of the therapeutic effect of orbital decompression may provide some clues to make the policy at treatment of DON. We explore the therapeutic effect of orbital decompression in patients with DON in both eyes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Ability to perform visual fields and VEP examination Without any serious systemic diseases Without any surgery on eyes in six months
- With any serious systemic diseases With any surgery on eyes in six months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Separate MPT Orbital decompression combined with MPT MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced. Orbital decompression combined MPT Orbital decompression combined with MPT Orbital decompression was performed by the same doctor with rich clinical experience. MPT should be implemented in the patients with obvious thyroid disorder before orbital decompression surgery which should only be performed when thyroid function was stabilized. The surgery was performed under general anesthesia. An arcuate incision was made in the skin 2 mm below the lower eyelid margin, and the tissue under the incision were separated to the periorbita and orbital septum. Part of the medial orbital wall, inferior orbital wall and partial tissue of ethmoidal sinus were removed, and an appropriate amount of adipose tissue was excised. MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced.
- Primary Outcome Measures
Name Time Method BCVA 6 months best corrected visual acuity in logMAR
IOP 6 months intraocular pressure in mmHg
proptosis 6 months proptosis in mm
upper eyelid retraction 6 months upper eyelid retraction in mm
CAS 6 months clinical activity score
- Secondary Outcome Measures
Name Time Method MD 6 months mean deviation of visual field in dB
PSD 6 months pattern standard deviation of visual field in dB
Trial Locations
- Locations (1)
Zhongshan Opthalmic Center
🇨🇳Guangdong, Guangdong, China