Characteristics of Prescreened Patients Who Did Not Participate in the Zoster Eye Disease Study.

PURPOSE: The Zoster Eye Disease Study (ZEDS) is a multicenter randomized clinical trial (RCT) funded by the National Eye Institute aiming to determine the efficacy of suppressive valacyclovir treatment in herpes zoster ophthalmicus (HZO) that enrolled fewer participants than planned (527/780, 67.6%). Understanding reasons for nonparticipation of likely eligible prescreened patients provides insights into patient populations that are not represented by ZEDS and barriers in clinical trials. METHODS: In this retrospective cohort study, HZO adults likely eligible for ZEDS with a history of a typical rash and a medical record within the past year of an episode of epithelial or stromal keratitis or iritis were prescreened at activated Participating Clinical Centers from 2017 to 2022 using a standard prescreening log. De-identified data including demographic information, reasons for exclusion because of ineligibility, and patient refusal were retrospectively entered into REDCap and analyzed. RESULTS: Prescreening logs with reasons for nonconsent (1244/1706, 72.9%) were included in the data set. Patients were excluded from the study (915/1244, 73.6%) because they did not meet all inclusion criteria (619/915, 67.7%) or met an exclusion criterion (296/915, 32.3%). Among the 12 exclusion criteria for the ZEDS study, immunocompromise (76/296, 25.7%) and renal insufficiency (50/296, 16.9%) were most frequently reported. Patient refusal to participate (327/1,244, 26.3%) was common. CONCLUSION: The most common reasons for ineligibility were immunocompromise and renal insufficiency. There may be benefits to long-term antiviral use in these populations not captured in ZEDS. A quarter (26.3%) of prescreened patients refused participation, showing the substantial impact of patient preferences on trial participation.

Increased Intraocular Pressure During Hemodialysis: Ocular Dialysis Disequilibrium.

A man in his early 70s presented with a 1-month history of headache, left-sided photophobia, periorbital pain, and redness occurring during hemodialysis. He had a history of ESKD secondary to diabetic nephropathy and of proliferative diabetic retinopathy. We observed elevated intraocular pressure during dialysis. A diagnosis of neovascular glaucoma with a compromised iridocorneal angle was made. Medical management of glaucoma and modifications to the hemodialysis regimen were initiated but were insufficient. The resolution of symptoms required surgical management, including cataract extraction with intraocular lens placement, pars plana vitrectomy, and peripheral retina endolaser, and placement of an Ahmed glaucoma drainage valve. This case illustrates the importance of attention to intraocular pressure and risk factors for glaucoma in patients treated with hemodialysis. Clinicians caring for patients treated by hemodialysis should consider hemodialysis-related elevation in intraocular pressure as a possible etiology for headache, visual changes, or ocular symptoms during dialysis and should pursue ophthalmic evaluation.