Materials and methods
eyelid swelling, diplopia, Sjögren’s syndrome, keratopathy, Allergic, exophthalmos, visual impairment, TAO, conjunctival congestion, proptosis, dry eye syndrome, DON, tissue damage, trauma
RHEUMATOID ARTHRITIS, DIPLOPIA, KERATOPATHY, EXOPHTHALMOS, DISEASE, AUTOIMMUNE DISEASES, SYSTEMIC LUPUS ERYTHEMATOSUS, MAY, PROPTOSIS, DRY EYE SYNDROME, DISEASES, COMPRESSIVE OPTIC NEUROPATHY, TAO
This was a prospective, randomized clinical study. A total of 80 mild or moderate-to-severe TAO patients (80 eyes) with dry eye syndrome were selected from the Ophthalmology Department of the Ninth People’s Hospital Affiliated to the Medical College of Shanghai Jiao Tong University from May to October 2020. The disease stages of all subjects were inactive. The severely affected eye in each patient was considered in the study. The inclusion criteria were as follows: ① Diagnosed as mild or moderate-to-severe TAO and the disease stage was inactive.; ② Diagnosed as dry eye syndrome. The exclusion criteria were as follows: ① Suffering from other ophthalmic diseases affecting the ocular surface; ② Suffering from autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s syndrome; ③ Previous ocular trauma or surgery; ④ Extremely severe TAO; ⑤ Allergic to drug ingredients. The content of this study was approved by the medical ethics committee of our hospital (approval No. sh9h-2019-t343-2, approved on March 18th, 2020) and registered in the Chinse clinical trial registry (Registration no. chictr2000033874, approved on 15/06/2020). Informed consent was signed by all subjects.TAO was diagnosed according to the Bartley standard [Mild TAO was defined as patients who could not meet the diagnostic criteria of moderate-to-severe TAO. Moderate-to-severe TAO was defined if a patient had no visual impairment but at least two of the following manifestations: ① Eyelid retraction: upper lid margin to reflex distance (MRD-1) was > 5 mm or a lower lid margin to reflex distance (MRD-2) was > 6 mm. ② Moderate-to-severe soft tissue damage (one of the following: moderate-to-severe eyelid swelling or moderate-to-severe conjunctival congestion); ③ At least 3 mm over the normal value of proptosis (Hertel exophthalmos of any eye ≥ 17 mm); ④ Stable or intermittent diplopia.Extremely severe TAO was defined as patients with compressive optic neuropathy (DON) and/or severe exposure keratopathy.The following was the judgment criteria for active and inactive TAO [TAO with dry eye syndrome was defined as fulfilling any of the following items based on the diagnosis of TAO [