Randomization, Assignment, and Follow-up
redness, uveitis, floaters, pain
ADVERSE EVENTS, REMISSION, UVEITIS, DECREASED VISION
Participants underwent simple randomization to receive the recommendation for early or deferred COVID-19 vaccination in a 1:1 ratio. Random assignment sequence was computer-generated, and individual allocations were known by telephone from a designated staff who kept the sequence and had no involvement in other parts of the trial. Patients and treating clinicians were aware of the trial assignment.Patients in the early vaccination group were recommended to receive COVID-19 vaccines as soon as possible, while patients in the deferred vaccination recommendation group were recommended to receive COVID-19 vaccines after the complete remission of uveitis. Our clinic did not provide COVID-19 vaccination service. We assessed patients’ uveitis status and only gave the recommendation to patients. Non-mRNA COVID-19 vaccines were free of charge and available in the community. During the trial, 2 inactivated SARS-CoV-2 vaccines, CoronaVac (Sinovac Biotech) and BBIBP-CorV (Sinopharm), and 1 protein subunit vaccine, ZF2001 (Anhui Zhifei Longcom Biopharmaceutical Co, Ltd), were available under emergency use authorization among people 12 years or older in China.Routine follow-up encounters occurred every month by telephone, and an in-person clinic visit was scheduled at month 3. At the telephone follow-up encounters, patients were asked about adherence to the recommendation, reasons for nonadherence, experiences of systemic adverse events, and uveitis symptoms, including the presence and duration of new-onset eye redness, eye pain, decreased vision, light sensitivity, and floaters. These queries were administered in a standardized telephone interview from the trial call center. Information on missed encounters could be completed in subsequent encounters provided that participants were brought back. In addition, all participants were repeatedly encouraged to follow the assigned vaccination recommendation during the telephone call. If the aforementioned symptoms or systemic adverse events were reported, patients would be instructed to return to the study site early or visit local hospitals for further clinical evaluation. We asked patients to provide their medical records from their local hospitals if any. Patients would receive best medical judgment and proper treatment, and intervention with trial recommendations would be terminated. At the month 3 in-person visit, patients underwent additional clinical evaluations, including slitlamp biomicroscopy, ophthalmoscopy, measurement of best-corrected visual acuity (BCVA), and other auxiliary examinations according to clinical needs.