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The Therapeutic Effect of Dysthyroid Optic Neuropathy

The Therapeutic Effect of Dysthyroid Optic Neuropathy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04096612
Enrollment
20
Registered
2019-09-20
Start date
2016-01-01
Completion date
2019-12-31
Last updated
2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Eye Disease

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.

Interventions

PROCEDUREOrbital decompression combined with MPT

Orbital decompression combined with MPT

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

\- Ability to perform visual fields and VEP examination Without any serious systemic diseases Without any surgery on eyes in six months

Exclusion criteria

\- With any serious systemic diseases With any surgery on eyes in six months

Design outcomes

Primary

MeasureTime frameDescription
IOP6 monthsintraocular pressure in mmHg
upper eyelid retraction6 monthsupper eyelid retraction in mm
CAS6 monthsclinical activity score
BCVA6 monthsbest corrected visual acuity in logMAR
proptosis6 monthsproptosis in mm

Secondary

MeasureTime frameDescription
MD6 monthsmean deviation of visual field in dB
PSD6 monthspattern standard deviation of visual field in dB

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026