Evaluation of a visual acuity eHealth tool in patients with cataract

To validate the Easee web-based tool for the assessment of visual acuity in patients who underwent cataract surgery.Setting:University Eye Clinic Maastricht, Maastricht, the Netherlands.Design:Prospective method comparison study.Methods:Subjects aged between 18 and 69 years who underwent cataract surgery on 1 or both eyes at the Maastricht University Medical Center+ were eligible to participate in this study. The uncorrected (UDVA) and corrected distance visual acuity (CDVA) assessments were performed using the web-based tool (index test) and conventional ETDRS and Snellen charts (reference tests). The outcomes of the different tests were expressed in logMAR, and a difference of <0.15 logMAR was considered clinically acceptable.Results:46 subjects with 75 operated eyes were included in this study. The difference of the UDVA between the web-based tool and ETDRS or Snellen was -0.05 ± 0.10 logMAR (P <.001 [0.15; -0.26]) and -0.04 ± 0.15 logMAR (P =.018 [0.24; -0.33]), respectively. For the CDVA, these differences were -0.04 ± 0.08 logMAR (P <.001 [0.13; -0.21]) and -0.07 ± 0.10 logMAR (P <.001 [0.13; -0.27]), respectively. The Pearson correlation coefficients between the web-based tool and ETDRS were maximally 0.94 and compared with Snellen 0.92. In total, 73% to 88% of the visual acuity measurement differences were within 0.15 logMAR.Conclusions:The web-based tool was validated for the assessment of visual acuity in patients who underwent cataract surgery and showed clinically acceptable outcomes in up to 88% of patients. Most of the participants had a positive attitude toward the web-based tool, which requires basic digital skills

Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty

Objective: To evaluate if an intraoperative-OCT (iOCT) optimized surgical protocol without prolonged overpressure is non-inferior to a standard protocol during Descemet membrane endothelial keratoplasty (DMEK). Methods: Sixty-five pseudophakic eyes of 65 patients with Fuchs endothelial dystrophy scheduled for routine DMEK were recruited in this prospective non-inferiority international multicenter randomized control trial. Subjects were randomized to the control arm (n=33) without iOCT-use and raising the intraocular pressure above normal physiological limits for 8 minutes (i.e., overpressure) or the intervention arm (n=32) with OCT-guidance to assess graft orientation and adherence, while refraining from prolonged overpressure. The primary outcome was the incidence of postoperative surgery-related adverse events (AE). The non-inferiority margin was set at a risk difference of 10%. Secondary outcomes included iOCT-aided surgical decision making, surgical times, and endothelial cell density (ECD) corrected distance visual acuity (CDVA) at 6 months follow-up. Results: In the intervention group, 12 subjects developed 13 AEs compared to 13 AEs in 10 subjects in the control group (P=0.644). The risk difference measured -0.32% (95%CI: -10.29 – 9.84). The ECD and CDVA did not differ between the two groups 3 and 6 months postoperatively (P=>0.05). Surgeons reported that iOCT aided surgical decision-making in 40% of cases. Surgery and graft unfolding time were, respectively, 13% and 27% shorter in the iOCT-group. Conclusions: iOCT-guided DMEK surgery with refraining from prolonged over-pressuring was non-inferior compared to conventional treatment. Surgery times were reduced considerably and iOCT aided surgical decision-making in 40% of cases. Refraining from prolonged overpressure did not affect postoperative ECD or CDVA. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03763721 (NCT03763721)

Cost-effectiveness of the ADVISE trial: An intraoperative OCT protocol in DMEK surgery

The intraoperative optical coherence tomography (iOCT) is recently introduced in Descemet membrane endothelial keratoplasty (DMEK) surgery, which aims to increase clinical performance and surgery safety. However, the acquisition of this modality is a substantial investment. The objective of this paper is to report on the cost-effectiveness of an iOCT-protocol in DMEK surgery with the Advanced Visualization in Corneal Surgery Evaluation (ADVISE) trial. This cost-effectiveness analysis uses data 6 months postoperatively from the multicentre prospective randomized clinical ADVISE trial. Sixty-five patients were randomized to usual care (n = 33) or the iOCT-protocol (n = 32). Quality-Adjusted Life Years (EQ-5D-5L), Vision-related Quality of Life (NEI-VFQ-25) and self-administered resources questionnaires were administered. Main outcome is the incremental cost-effectiveness ratio (ICER) and sensitivity analyses. The iOCT protocol reports no statistical difference in ICER. For the usual care group compared with the iOCT protocol, respectively, the mean societal costs are €5027 compared with €4920 (Δ€107). The sensitivity analyses report the highest variability on time variables. This economic evaluation learned that there is no added value in quality of life or cost-effectiveness in using the iOCT protocol in DMEK surgery. The variability of cost variables depends on the characteristics of an eye clinic. The added value of iOCT could gain incrementally by increasing surgical efficiency, and aiding in surgical decision-making

Reduced corneal nerve fibre length in prediabetes and type 2 diabetes: The Maastricht Study

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Corneal Transplantation for Infectious Keratitis: A Prospective Dutch Registry Study

Purpose: The aim of this study was to analyze real-world practice patterns and graft survival after corneal transplantation for infectious keratitis in the Netherlands. Methods: All consecutive keratoplasties for infectious keratitis registered in the Netherlands Organ Transplant Registry were included. Graft survival was analyzed using Kaplan–Meier survival curves with Cox regression to compare the 3 most common pathogens with subgroup analysis for type and reason of transplantation, sex, and graft size. Multivariable analysis was performed using the same explanatory factors. Results: Between 2007 and 2017, 1111 keratoplasties for infectious keratitis were registered in the Netherlands Organ Transplant Registry. The most common pathogens were viruses (n = 437), bacteria (n = 271), and Acanthamoeba (n = 121). Human leukocyte antigen (HLA) matching did not provide a significant survival benefit, whereas emergency procedures showed worse graft survival [hazard ratio (HR) = 0.40, P = 0.120; HR = 2.73, P 8.5 mm was significantly worse than graft size 8.5 mm (HR = 2.062, P = 0.010). In therapeutic keratoplasty, graft survival was significantly worse for Acanthamoeba than viral keratitis (HR = 2.36, P = 0.008). In the multivariable model, adjusting for graft size, type, and reason for transplantation, viral and bacterial keratitis did not differ significantly in graft survival, and Acanthamoeba showed a significantly worse prognosis (vs. viral keratitis, HR = 2.30, P 8.5 mm showed poor survival. In optical keratoplasty, survival is high for all pathogens, whereas in therapeutic keratoplasty Acanthamoeba shows poor outcome

Advancing COVID-19 diagnostics:rapid detection of intact SARS-CoV-2 using viability RT-PCR assay

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). Commonly used methods for both clinical diagnosis of SARS-CoV-2 infection and management of infected patients involve the detection of viral RNA, but the presence of infectious virus particles is unknown. Viability PCR (v-PCR) uses a photoreactive dye to bind non-infectious RNA, ideally resulting in the detection of RNA only from intact virions. This study aimed to develop and validate a rapid v-PCR assay for distinguishing intact and compromised SARS-CoV-2. Propidium monoazide (PMAxx) was used as a photoreactive dye. Mixtures with decreasing percentages of intact SARS-CoV-2 (from 100% to 0%) were prepared from SARS-CoV-2 virus stock and a clinical sample. Each sample was divided into a PMAxx-treated part and a non-PMAxx-treated part. Reverse transcription-PCR (RT-PCR) using an in-house developed SARS-CoV-2 viability assay was then applied to both sample sets. The difference in intact SARS-CoV-2 was determined by subtracting the cycle threshold (Ct) value of the PMAxx-treated sample from the non-PMAxx-treated sample. Mixtures with decreasing concentrations of intact SARS-CoV-2 showed increasingly lower delta Ct values as the percentage of intact SARS-CoV-2 decreased, as expected. This relationship was observed in both high and low viral load samples prepared from cultured SARS-CoV-2 virus stock, as well as for a clinical sample prepared directly from a SARS-CoV-2 positive nasopharyngeal swab. In this study, a rapid v-PCR assay has been validated that can distinguish intact from compromised SARS-CoV-2. The presence of intact virus particles, as determined by v-PCR, may indicate SARS-CoV-2 infectiousness.</p

Anesthesia techniques and the risk of complications as reflected in the European Registry of Quality Outcomes for Cataract and Refractive Surgery

Purpose: To determine the trends in anesthesia techniques for cataract surgery over the past decade and their relationship to surgical complications. Setting: Clinics affiliated with the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO). Design: Retrospective cross-sectional register-based study. Methods: Variables include patient demographics, visual acuity, ocular comorbidities, surgery characteristics, intraoperative complications, and postoperative complications for the study period from January 2008, to December 2018. The anesthesia methods registered in the EUREQUO and included in the study are topical, combined topical and intracameral, sub-Tenon, regional, and general anesthesia. Multivariate logistic regression models for each complication were constructed to estimate the adjusted odds ratio (OR) and 95% CIs. Results: Complete data were available of 1 354 036 cataract surgeries. Topical anesthesia increased significantly over time (from 30% to 76%, P < .001). Sub-Tenon and regional anesthesia decreased (from 27% and 38% to 16% and 6%, respectively, P < .001), and general and combined topical and intracameral anesthesia remained stable (around 2%). Sub-Tenon (OR, 0.80; 95% CI, 0.71-0.91, P < .001), regional (0.74; 95% CI, 0.71-0.78, P < .001), general (0.53; 95% CI, 0.50-0.56, P < .001), and intracameral anesthesia (0.76; 95% CI, 0.64-0.90, P = .001) carried a significantly decreased risk of posterior capsule rupture (PCR), with and without dropped nucleus, compared with topical anesthesia. The risk of endophthalmitis was significantly lower with regional anesthesia compared with topical anesthesia (OR, 0.60; 95% CI, 0.44-0.82, P = .001). Conclusions: The use of topical anesthesia for cataract surgery increased over time. Topical anesthesia is associated with an increased risk of PCR with and without dropped nucleus, and endophthalmitis

Allogeneic Serum Eye Drops: A Randomized Clinical Trial to Evaluate the Clinical Effectiveness of Two Drop Sizes

Introduction: Allogeneic serum from blood donors is starting to be used to treat patients with dry eye disease (DED). However, the optimal dose is not known. We therefore aimed to evaluate the clinical efficaciousness and user-friendliness of micro-sized versus conventional-sized allogeneic serum eye drops (SEDs). Methods: In a randomized trial, patients with DED first receive micro-sized SEDs (7 µl/unit) for 1 month, followed by a 1-month washout, before receiving conventional-sized SEDs (50 µl/unit) for 1 month; or vice versa. The primary endpoint was the Ocular Surface Disease Index (OSDI) score. Secondary endpoints were tear break-up time (TBT), tear production (TP), and presence of corneal punctate lesions (CP). The user-friendliness of both application systems was also compared. A linear mixed model for cross-over design was applied to compare both treatments. Results: Forty-nine patients completed the trial. The mean OSDI score significantly improved from 52 ± 3 to 41 ± 3 for micro-sized SEDs, and from 54 ± 3 to 45 ± 3 for conventional-sized SEDs. Non-inferiority (margin = 6) of micro-sized SEDs was established. We demonstrate a significant improvement for TBT in case of conventional-sized SEDs and for CP in both treatment groups. TP trended towards an improvement in both treatment groups. The user-friendliness of the conventional drop system was significantly higher. Conclusions: For the first time, non-inferiority of micro-sized allogeneic SEDs was established. The beneficial effect of both SED volumes was similar as measured by the OSDI score. Although user-friendliness of the micro drop system was significantly lower, it is an attractive alternative as it saves valuable donor serum. Trial Registration: ClinicalTrials.gov (NCT03539159)

Web-based telemonitoring of visual function and self-reported postoperative outcomes in cataract care: international multicenter randomized controlled trial

Purpose: To compare web-based, self-administered follow-up after cataract surgery to conventional face-to-face follow-up. Setting: Eye clinics in the Netherlands, Austria, and Germany. Design: Randomized controlled trial with an embedded method comparison study (ClinicalTrials. gov: NCT04809402). Methods: Routine patients with cataract were randomized into 2 groups: The telemonitoring group undertook web-based vision self-assessments and questionnaires from home, while the usual care group received conventional care. All participants had a 4- to 6-week postoperative clinic visit for safety and validation purposes. Outcomes included, the web test's accuracy for assessing postoperative visual acuity (VA) and refractive error, adverse event rates, and patient-reported outcome measurements (PROMs). Results: 94 participants (188 eyes) were enrolled. Web-based uncorrected distance VA testing demonstrated a negligible mean difference (-0.03 ± 0.14 logMAR) when compared with conventional Early Treatment Diabetic Retinopathy Study chart testing, with 95% limits of agreement ranging from -0.30 to 0.24 logMAR. The web-based refraction assessment overestimated the postoperative refractive error (mean difference in spherical equivalent 0.15 ± 0.67 diopters), resulting in a poorer corrected distance VA compared with subjective refraction (mean 0.1 vs -0.1 logMAR). Rates of adverse events and unscheduled consultations were minimal across both groups. Preoperative and postoperative PROM questionnaires had a 100% response rate. Visual functioning (Catquest-9SF and National Eye Institute Visual Function Questionnaire-25) improved postoperatively (mean improvement -0.80 and 16.70, respectively) and did not significantly differ between the 2 groups. Conclusions: The patients with cataract in this study effectively provided postoperative outcome data using a web interface. Both conventional and web-based follow-ups yielded similar PROMs and adverse event rates. Future developments should reduce the variability in the web-based VA test and yield representative refraction outcomes