Thyroid eye disease
Conditions
Interventions
TED patients with diplopia group:No intervention
TED patients without diplopia group:No intervention
Healthy control group:No intervention
TED patients with dysthyroid optic neuropathy group:No intervention
TED patients without dysthyroid optic neuropathy group:No intervention
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria for thyroid eye disease patients (TED) with or without diplopia: (1) age: 18-65 years (inclusive); (2) diagnosis of thyroid eye disease according to the 2022 Chinese Guidelines for Diagnosis and Treatment of TED; (3) uncorrected or best-corrected visual acuity >=1.0; and (4) presence or absence of diplopia as assessed by Bahn-Gorman score (score >0 indicates diplopia presence, score 0 indicates absence), enabling classification into TED with diplopia and TED without diplopia groups. 2.Inclusion criteria for patients with thyroid eye disease (TED), with or without dysthyroid optic neuropathy (DON): (1) age: 18-65 years (inclusive); (2) history of diagnosed thyroid disease or a history of thyroid dysfunction; and (3) presence or absence of DON (at least three of the following clinical manifestations, with a clear diagnosis of DON confirmed by computed tomography (CT) or magnetic resonance imaging (MRI), and at least one other clinical auxiliary examination necessary for the diagnosis of DON): 1) clinical manifestations: progressive visual acuity decline, visual field defect, color vision impairment, proptosis, periorbital edema, lid retraction, upper eyelid lag, ocular motility disorders, diplopia, ptosis, epiphora, conjunctival congestion, chemosis, ocular pain, photophobia, lacrimation, etc.; 2) clinical auxiliary examinations: visual acuity measurement shows decreased visual acuity; color vision test shows abnormal color vision; intraocular pressure (or) increased proptosis greater than the normal upper limit (14 mm); visual field examination shows visual field defects, average defect, and pattern deviation differences; visual evoked potential (VEP) shows P100 latency delay, reduced amplitude; ocular CT or MRI shows orbital apex muscle enlargement or (and) intraorbital fat increase, or compression of the optic nerve by multiple congestions of intraorbital fat, proptosis, eyelid edema; ocular examination shows papilledema, unclear margins; optical coherence tomography (OCT) shows early thickening of the retinal nerve fiber layer, and later thinning, etc. 3.Inclusion criteria for healthy controls: (1) age: 18-65 years (inclusive); (2) uncorrected or best-corrected visual acuity >=1.0; and (3) ability to comprehend and cooperate with examination procedures.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for thyroid eye disease patients with or without diplopia include: (1) concurrent ocular pathologies; (2) history of substance abuse (drugs, alcohol, or other addictive substances); (3) pregnancy or lactation status; (4) pre-existing neurological disorders, history of cranial trauma, or significant systemic diseases; (5) inability to complete all required clinical evaluations; and (6) contraindications for MRI procedures (including implanted cardiac pacemakers, metallic prostheses, or prior head/spinal injuries necessitating neurosurgical management). 2. Exclusion criteria for thyroid eye disease patients with or without dysthyroid optic neuropathy include: (1) concurrent ocular pathologies; (2) substance dependence (drugs, alcohol or other addictive substances); (3) pregnancy or lactation; (4) neurological disorders, head trauma history or systemic diseases; (5) non-compliance with required examinations; and (6) MRI contraindications (cardiac pacemakers, metallic prostheses, or history of head/spine trauma requiring neurosurgical intervention). 3. Exclusion criteria for healthy subjects: (1) ocular diseases; (2) substance dependence (drugs, alcohol or other addictive substances); (3) pregnancy or lactation; (4) neurological disorders, history of head trauma or systemic diseases; (5) inability to complete required examinations; and (6) MRI contraindications (cardiac pacemakers, metallic implants, or history of head/spinal trauma requiring neurosurgical intervention).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Thyroid function and antibody indices;EEG;Adult Strabismus-20 Questionnaire;Clinical Activity Score;Low Vision Quality of Life Questionnaire;Graves' Ophthalmopathy Quality of Life Questionnaire;Visual Light Sensitivity Questionnaire;Visual function;Diplopia Questionnaire;Hamilton Depression Rating Scale;Bahn-Gorman Scale;Hamilton Anxiety Rating Scale; | — |
Countries
China
Contacts
Public ContactHuifang Zhou
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed