Belgian Endothelial Surgical Transplant of the Cornea (BEST cornea) protocol: clinical and patient-reported outcomes of Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) - a multicentric, randomised, parallel group pragmatic trial in corneal endothelial decompensation.

OBJECTIVES: Corneal blindness is the third most frequent cause of blindness globally. Damage to the corneal endothelium is a leading indication for corneal transplantation, which is typically performed by lamellar endothelial keratoplasty. There are two conventional surgical techniques: Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK). The purpose of this study is to compare both techniques. METHODS AND ANALYSIS: The trial compares UT-DSAEK and DMEK in terms of clinical and patient reported outcomes using a pragmatic, parallel, multicentric, randomised controlled trial with 1:1 allocation with a sample size of 220 participants across 11 surgical centres. The primary outcome is the change in best-corrected visual acuity at 12 months. Secondary outcomes include corrected and uncorrected vision, refraction, proportion of high vision, quality of life (EQ-5D-5L and VFQ25), endothelial cell counts and corneal thickness at 3, 6 and 12 months follow-up appointments. Adverse events will also be compared 12 months postoperatively. ETHICS AND DISSEMINATION: The protocol was reviewed by ethical committees of 11 participating centres with the sponsor centre issuing the final definitive approval. The results will be disseminated at clinical conferences, by patient partner groups and open access in peer-reviewed journals. GOVERNANCE OF THE TRIAL: Both, trial management group and trial steering committee, are installed with representatives of all stakeholders involved including surgeons, corneal bankers, patients and external experts. TRIAL REGISTRATION NUMBER: NCT05436665.

Bilateral Corneal Perforation in a Patient Under Anti-PD1 Therapy.

ABSTRACT: Immune checkpoint inhibition has improved the clinical outcomes for numerous patients with cancer. However, the downside is a whole new spectrum of immune-related adverse events. We report a 68-year-old man with a history of nonsmall cell lung cancer presenting with a spontaneous corneal perforation in the right eye after 22 cycles of pembrolizumab. In addition, a chronic central nonhealing epithelial defect developed after performing a penetrating keratoplasty. Treatment with autologous serum drops resulted in complete healing of the corneal ulcer, where other conventional therapies had no effect. One month after reinitiating pembrolizumab therapy, our patient presented again with a corneal perforation in the fellow eye. This case describes relapsing sterile ulcerations associated with pembrolizumab use and presents an unexpected cure.

Dose-response in choroidal melanoma.

PURPOSE: In choroidal melanoma the radiation threshold dose for local control remains largely unknown. The present study examined a group of patients that received a wide range of minimum tumor dose in order to investigate a dose-response relationship. A literature review is performed to compare our results with available evidence in brachytherapy and charged particle external beam radiotherapy. MATERIALS AND METHODS: A retrospective study was conducted on all choroidal melanomas treated with Strontium-90 (Sr-90) at the University Hospital of Leuven between 1983 and 2012. Local failure was defined as primary endpoint and was estimated according to the competing risk method. RESULTS: In 135 patients, the minimum tumor dose (Dmin) ranged from 0 Gy to 287 Gy (median: 27.6 Gy). Multivariable analysis revealed Dmin ≥ 65 Gy (p = 0.04; HR = 0.09) and tumor distant from the optic disc (p < 0.001, HR = 0.09) to be independent variables favoring local control. The scleral dose, the tumor diameter and tumor height did not significantly affect local failure in multivariate analysis. CONCLUSION: This is the first study to examine a group of patients treated with a Dmin ranging from 0 Gy to >250 Gy. Treatment with a Dmin of 65 Gy is necessary to achieve durable tumor response. The dose-response data provided by our study could be used for the design of future trials examining the ideal dose for the treatment of choroidal melanoma with brachytherapy or charged particle external beam radiotherapy.

Corneal Cross-Linking in Pediatric Patients With Progressive Keratoconus.

PURPOSE: To evaluate corneal cross-linking (CXL) in the treatment of keratoconus in pediatric patients. Specifically, this study investigates the impact of CXL on uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (BDVA), manifest refraction, keratometry (K) measurements, and higher order aberrations. METHODS: This is a retrospective, observational case series of patients 18 years old or younger with progressive keratoconus who underwent CXL from January 2009 to August 2013. Preoperative and 1-year postoperative data including BDVA, manifest refraction, mean K readings, and corneal aberration measurements were extracted from clinical charts and topographical imaging. Visual acuity was converted to logarithm of the minimum angle of resolution (logMAR) scale, and mean refractive spherical equivalent (MRSE) was calculated from manifest refraction. RESULTS: The group consisted of 39 eyes from 28 patients, including 21 males and 7 females (mean age = 16.3 years, range: 11-18, standard deviation [SD] = 1.81). UDVA did not change significantly (preoperative UDVA = 1.20 logMAR, SD = 0.57, and postoperative UDVA = 0.90 logMAR, SD = 0.67, P = 0.19). BDVA did not change significantly (preoperative BDVA = 0.34 logMAR, SD = 0.27, and postoperative BDVA = 0.34 logMAR, SD = 0.23, P = 0.50). There was no significant change in mean K (preoperative K = 48.49, SD = 5.44, and postoperative K = 48.25, SD = 4.74, P = 0.34). Mean MRSE did not change significantly (preoperative MRSE = -3.29 D, SD = 4.04, and postoperative MRSE = -3.53 D, SD = 4.07, P = 0.31). Corneal aberration measurements were available for 10 eyes, and stability of measurements was demonstrated. There were no complications noted. CONCLUSIONS: This study suggests that CXL is a safe and effective procedure that halts the progression of keratoconus in pediatric patients at 1-year follow-up. To validate these findings, longer follow-up is required.

Series of extranodal natural killer/T-cell lymphoma, nasal type, with periorbital involvement.

PURPOSE: To describe the clinical presentation, diagnosis and treatment of periorbital extranodal natural killer/T-cell lymphoma, nasal type. METHODS: Case series of three patients with periorbital involvement of extranodal natural killer/T-cell lymphoma, nasal type, of whom clinical data, orbital imaging and immunohistochemical analysis were collected. For the purpose of this study, all histopathological and immunohistochemical slides were re-examined. RESULTS: All patients presented with painless eyelid swelling and a history of sinonasal disease, of whom one with bilateral panuveitis, not responding to systemic antibiotics. Extraocular muscle involvement was present in 2 cases upon presentation and in 1 case later on. Initial paranasal and orbital biopsies were negative in 2 patients, with only the second orbital biopsy leading to the diagnosis. Natural killer/T-cell and cytotoxic markers were present in all cases, as well as Epstein-Barr virus encoded RNA in situ hybridization. The patients died respectively 5, 9 and 35 months from diagnosis despite treatment with chemotherapy and radiotherapy. CONCLUSION: Extranodal natural killer/T-cell lymphoma, nasal type, should be suspected in a painless periorbital cellulitis with chronic sinusitis, not responding to conventional therapy. A high index of suspicion is necessary in biopsies showing angiodestruction and necrosis. Epstein-Barr virus encoded RNA in situ hybridization and expert hematopathologist consultation is necessary to decrease the delay in diagnosis.