Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial.

BACKGROUND: Cataract surgery has become one of the most performed surgical procedures worldwide. Postoperative management consists of routine clinical examinations to assess post-operative visual function and detect possible adverse events. Due to the low incidence of complications, the majority of clinic visits after cataract surgery are uneventful. Nonetheless, valuable time and hospital resources are consumed. We hypothesize that remote post-operative follow-up involving teleconsultations and self-assessments of visual function and health status, could be a valid alternative to face-to-face clinical examinations in selected patient groups. The practice of remote follow-up after cataract surgery has not yet been evaluated. The aim of this study is to investigate the validity, safety and cost-effectiveness of remote cataract surgery follow-up, and to report on the patients' experiences with remotely self-assessing visual function. METHODS: This study is a multicenter, open-label, randomized controlled trial. Patients planned for cataract surgery on both eyes, without ocular comorbidities, are eligible for participation. Participants will be allocated (1:1) into one of the two study groups: 'telemonitoring' or 'usual care'. Participants in the 'telemonitoring' group will perform in-home assessments after cataract surgery (remote web-based eye exams and digital questionnaires on their own devices). Participants in the 'usual care' group will have regular post-operative consultations, according to the study site's regular practice. Outcome measures include accuracy of the web-based eye exam for assessing visual acuity and refraction, patient-reported outcome measures (visual function and quality of life), adverse events, and cost aspects. DISCUSSION: Investigating remote follow-up after cataract surgery fits the current trends of digitization of health care. We believe that remote self-care can be a promising avenue to comply with the increasing demands of cataract care. This randomized controlled trial provides scientific evidence on this unmet need and delivers the desired insights on (cost)effectiveness of remote follow-up after cataract surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04809402. Date of registration: March 22, 2021.

Efficacy of customized corneal crosslinking versus standard corneal crosslinking in patients with progressive keratoconus (C-CROSS study): study protocol for a randomized controlled trial.

BACKGROUND: Keratoconus is a degenerative disorder of the cornea leading to a protrusion and thinning with loss of visual acuity. The only treatment to halt the progression is corneal crosslinking (CXL), which uses riboflavin and UV-A light to stiffen the cornea. Recent ultra-structural examinations show that the disease is regional and does not affect the entire cornea. Treating only the affected zone with CXL could be as good as the standard CXL, that treats the entire cornea. METHODS: We set up a multicentre non-inferiority randomized controlled clinical trial comparing standard CXL (sCXL) and customized CXL (cCXL). Patients between 16 and 45 years old with progressive keratoconus were included. Progression is based on one or more of the following changes within 12 months: 1 dioptre (D) increase in keratometry (Kmax, K1, K2); or 10% decrease of corneal thickness; or 1 D increase in myopia or refractive astigmatism, requiring corneal crosslinking. DISCUSSION: The goal of this study is to evaluate whether the effectiveness of cCXL is non-inferior to sCXL in terms of flattening of the cornea and halting keratoconus progression. Treating only the affected zone could be beneficial for minimalizing the risk of damaging surrounding tissues and faster wound healing. Recent non-randomized studies suggest that a customized crosslinking protocol based on the tomography of the patient's cornea may stop the progression of keratoconus and result in flattening of the cornea. TRIAL REGISTRATION: This study was prospectively registered at ClinicalTrials.gov on August 31st, 2020, the identifier of the study is NCT04532788.

The evaluation of an online nurse-assisted eye-screening tool in older adults receiving home healthcare.

PURPOSE: To investigate the agreement between an online nurse-assisted eye-screening tool and reference tests in older adults receiving home healthcare and to collect user experiences. METHODS: Older adults (65+) receiving home healthcare were included. Home healthcare nurses assisted in administering the eye-screening tool at participants' homes. Approximately 2 weeks later, a researcher administered reference tests at participants' homes. Experiences from participants and home healthcare nurses were collected. Agreement in outcomes (distance and near visual acuity, with the latter being measured using two different optotypes, and macular problems) between the eye-screening tool and reference clinical testing was compared. A difference of less than ±0.15 logMAR was considered acceptable. RESULTS: A total of 40 participants were included. Here, we describe the results for the right eye; results for the left eye were similar. The mean difference between the eye-screening tool and reference tests for distance visual acuity was 0.02 logMAR. The mean difference between the eye-screening tool and reference tests using two different optotypes for near visual acuity was 0.06 and 0.03 logMAR, respectively. The majority of the individual data points were within the ±0.15 logMAR threshold (75%, 51% and 58%, respectively). The agreement between tests for macular problems was 75%. Participants and home healthcare nurses were generally satisfied with the eye-screening tool, although remarks for further improvements were made. CONCLUSIONS: The eye-screening tool is promising for nurse-assisted eye screening in older adults receiving home healthcare, with the mostly satisfactory agreement. After implementing the eye-screening tool in practice, cost-effectiveness needs to be investigated.

Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Clinical Trial.

PURPOSE: To compare best spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane endothelial keratoplasty (DMEK) and ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). DESIGN: Prospective, multicenter randomized controlled trial. PARTICIPANTS: Fifty-four pseudophakic eyes of 54 patients with corneal endothelial dysfunction resulting from Fuchs endothelial corneal dystrophy were enrolled in 6 corneal centers in The Netherlands. METHODS: Participants were allocated to DMEK (n = 29) or UT-DSAEK (n = 25) using minimization randomization based on preoperative BSCVA, recipient central corneal thickness, gender, age, and institution. Donor corneas were prestripped and precut for DMEK and UT-DSAEK, respectively. Six corneal surgeons participated in this study. MAIN OUTCOME MEASURES: The primary outcome measure was BSCVA at 12 months after surgery. RESULTS: Central graft thickness of UT-DSAEK lamellae measured 101 µm (95% confidence interval [CI], 90-112 µm). Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR] [95% CI 0.08-0.22 logMAR] vs. 0.22 logMAR [95% CI 0.16-0.27 logMAR]; P = 0.15), 6 months (0.11 logMAR [95% CI 0.05-0.17 logMAR] vs. 0.16 logMAR [95% CI 0.12-0.21 logMAR]; P = 0.20), and 12 months (0.08 logMAR [95% CI 0.03-0.14 logMAR] vs. 0.15 logMAR [95% CI 0.10-0.19 logMAR]; P = 0.06). Twelve months after surgery, the percentage of eyes reaching 20/25 Snellen BSCVA was higher in DMEK compared with UT-DSAEK (66% vs. 33%; P = 0.02). Endothelial cell density did not differ significantly 12 months after DMEK and UT-DSAEK (1870 cells/mm2 [95% CI 1670-2069 cells/mm2] vs. 1612 cells/mm2 [95% CI 1326-1898 cells/mm2]; P = 0.12). Both techniques induced a mild hyperopic shift (12 months: +0.22 diopter [D; 95% CI -0.23 to 0.68 D] for DMEK vs. +0.58 D [95% CI 0.13-1.03 D] for UT-DSAEK; P = 0.34). CONCLUSIONS: Descemet membrane endothelial keratoplasty and UT-DSAEK did not differ significantly in mean BSCVA, but the percentage of eyes achieving 20/25 Snellen vision was significantly higher with DMEK. Endothelial cell loss did not differ significantly between the treatment groups, and both techniques induced a minimal hyperopic shift.

Validation of an Independent Web-Based Tool for Measuring Visual Acuity and Refractive Error (the Manifest versus Online Refractive Evaluation Trial): Prospective Open-Label Noninferiority Clinical Trial.

BACKGROUND: Digital tools provide a unique opportunity to increase access to eye care. We developed a Web-based test that measures visual acuity and both spherical and cylindrical refractive errors. This test is Conformité Européenne marked and available on the Easee website. The purpose of this study was to compare the efficacy of this Web-based tool with traditional subjective manifest refraction in a prospective open-label noninferiority clinical trial. OBJECTIVE: The aim of this study was to evaluate the outcome of a Web-based refraction compared with a manifest refraction (golden standard). METHODS: Healthy volunteers from 18 to 40 years of age, with a refraction error between -6 and +4 diopter (D), were eligible. Each participant performed the Web-based test, and the reference test was performed by an optometrist. An absolute difference in refractive error of <0.5 D was considered noninferior. Reliability was assessed by using an intraclass correlation coefficient (ICC). Both uncorrected and corrected visual acuity were measured. RESULTS: A total of 200 eyes in 100 healthy volunteers were examined. The Web-based assessment of refractive error had excellent correlation with the reference test (ICC=0.92) and was considered noninferior to the reference test. Uncorrected visual acuity was similar with the Web-based test and the reference test (P=.21). Visual acuity was significantly improved using the prescription obtained by using the Web-based tool (P<.01). The Web-based test provided the best results in participants with mild myopia (ie, <3 D), with a mean difference of 0.02 (SD 0.49) D (P=.48) and yielding a corrected visual acuity of >1.0 in 90% (n=77) of participants. CONCLUSIONS: Our results indicate that Web-based eye testing is a valid and safe method for measuring visual acuity and refractive error in healthy eyes, particularly for mild myopia. This tool can be used for screening purposes, and it is an easily accessible alternative to the subjective manifest refraction test. TRIAL REGISTRATION: Clinicaltrials.gov NCT03313921; https://clinicaltrials.gov/ct2/show/NCT03313921.

Performing corneal crosslinking under local anaesthesia in patients with Down syndrome.

PURPOSE: To report on the ability to perform corneal crosslinking (CXL) under local anaesthesia for the treatment of keratoconus in patients with Down syndrome. METHODS: Nine eyes of seven patients with both keratoconus and Down syndrome were scheduled for an epithelium-off CXL procedure under local anaesthesia. Exclusion criteria were a corneal thickness under 400 µm and the presence of corneal scars. A standardized clinical decision tool was used to estimate patient cooperation and the likelihood for a successful procedure under local rather than general anaesthesia. RESULTS: In seven eyes, the CXL was completed successfully. The treatment was aborted in two eyes due to insufficient corneal thickness (<400 µm) prior to ultraviolet-A irradiation, even after employing hypoosmolar riboflavin. No adverse events occurred post-operatively, except for one case of delayed epithelial healing (23 days). CONCLUSIONS: With a proper patient selection, CXL under local anaesthesia can be achieved in patients with Down syndrome.

Cost-Effectiveness Analysis of Corneal Collagen Crosslinking for Progressive Keratoconus.

PURPOSE: To evaluate the cost effectiveness of corneal collagen crosslinking (CXL) for progressive keratoconus from the healthcare payer's perspective. DESIGN: A probabilistic Markov-type model using data from published clinical trials and cohort studies. PARTICIPANTS: Two identical cohorts, each comprising 1000 virtual patients with progressive bilateral keratoconus, were modeled; one cohort underwent CXL and the other cohort received no intervention. METHODS: Both cohorts were modeled and evaluated annually over a lifetime. Quality-adjusted life years (QALYs), total cost, disease progression, and the probability of corneal transplantation, graft failure, or both were calculated based on data from published trials and cohort studies. These outcomes were compared between the 2 cohorts. In our base scenario, the stabilizing effect of CXL was assumed to be 10 years; however, longer durations also were analyzed. One-way sensitivity analyses were performed to test the robustness of the outcomes. MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratio (ICER), defined as euros per QALY. RESULTS: Assuming a 10-year effect of CXL, the ICER was €54 384/QALY ($59 822/QALY). When we adjusted the effect of CXL to a lifelong stabilizing effect, the ICER decreased to €10 149/QALY ($11 163/QALY). Other sensitivity and scenario analyses that had a relevant impact on ICER included the discount rate, visual acuity before CXL, and healthcare costs. CONCLUSIONS: Corneal collagen crosslinking for progressive keratoconus is cost effective at a willingness-to-pay threshold of 3 times the current gross domestic product (GDP) per capita. Moreover, a longer stabilizing effect of CXL increases cost effectiveness. If CXL had a stabilizing effect on keratoconus of 15 years or longer, then the ICER would be less than the 1 × GDP per capita threshold and thus very cost effective.

Intraoperative optical coherence tomography in descemet stripping automated endothelial keratoplasty: pilot experiences.

PURPOSE: To assess the added value of intraoperative optical coherence tomography (iOCT) in evaluating graft adhesion and graft interface in patients undergoing descemet's stripping automated endothelial keratoplasty (DSAEK). METHODS: This is a prospective single-center case series comprising 8 eyes of 8 patients consecutively scheduled for DSAEK surgery. iOCT imaging was performed after insertion of the graft, after pressurizing the eye, and at the end of surgery (three images per surgery). At each stage of surgery, corneal thickness and the widest gap between the recipient and the graft (i.e., maximal interface width) were measured using an image processing tool. Follow-up measurements were taken at 1 day, 3 and 6 months, post-operatively. RESULTS: Imaging was performed in 21 of 24 scheduled imaging intervals, and required little to no additional surgical time. At the end of surgery, iOCT showed persisting interfaces in six cases. One case showed a full graft detachment necessitating surgical intervention. CONCLUSION: Real-time iOCT is a safe, efficient, and useful tool in assessing graft adherence in DSAEK surgery. With adequate analysis software, iOCT has the potential to be a paradigm-shifting development in posterior lamellar surgery and could aid the clinician in further lowering the rates of graft dislocation after DSAEK.

Predictors for treatment outcomes after corneal crosslinking for keratoconus: a validation study.

Previous research suggested that baseline corrected distance visual acuity (CDVA) and maximum keratometry (Kmax) are the predictors for effectiveness of corneal crosslinking (CXL) for keratoconus. The aim of this study was to validate the previously determined predictors in a new treatment cohort. A prospective cohort of 112 eyes in 90 consecutive patients was used to validate the results of 102 eyes in 79 patients from our previous prospective cohort. All patients were treated using epithelium-off corneal CXL in a tertiary hospital setting. Primary outcomes were changes in CDVA (LogMAR) and Kmax between baseline and 1-year post-treatment. Predictive factors for both outcomes were determined using univariable and multivariable analyses. Lower pretreatment CDVA was found to be the sole independent factor predicting an improvement in CDVA 1 year after CXL (ß coefficient: -0.476, P < 0.01). Kmax flattening is more likely to take place in eyes with preoperative central cones (ß coefficient: 0.655, P < 0.01). These results are consistent with our initial research and indicate high reproducibility in the new cohort. The previously postulated prediction model for postoperative CDVA showed limited predictive value in the validation cohort (R 2 = 0.15). The clinical implication of these results is that patients with lower pretreatment visual acuity are more likely to benefit from CXL (with respect to visual acuity), and patients with more central cones will benefit more in terms of cone flattening. Furthermore, those results can be used to guide customization of the crosslinking treatment.

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.

Health economic evaluation of a nurse-assisted online eye screening in home healthcare to reduce avoidable vision impairment (iScreen): study protocol for a cluster randomized controlled trial.

BACKGROUND: Among older people undiagnosed and untreated vision impairment and blindness are common. The leading causes are uncorrected refractive errors and cataracts. Vision problems are associated with a lower quality of life, several health problems, and a higher chance of falling accidents and fractures. To eliminate avoidable vision impairment and blindness, targeted eye screening programs are recommended. Older patients, receiving home healthcare, have not yet been considered as a population at risk who could benefit from eye screening. METHODS: A cluster-randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of online nurse-assisted eye screening in home healthcare, compared to care as usual, in reducing avoidable vision impairment. A healthcare and societal perspective will be used. The study will be performed in collaboration with several home healthcare organizations in the Netherlands. The online eye screening consists of near and distance visual acuity, followed by an Amsler grading test. Measurements in both groups will take place at baseline and after 6 and 12 months of follow-up. A total of 240 participants will be recruited. Older men and women (65 +), who receive home-based nursing and are cognitively able to participate, will be included. The primary outcome will be the change of two lines or more on the Colenbrander-1 M visual acuity chart between baseline and 12-month follow-up. DISCUSSION: An eye screening for populations at risk contributes to the detection of undiagnosed and untreated vision impairment. This may reduce the health-related consequences of vision loss and the high economic burden associated with vision impairment. TRIAL REGISTRATION: ClinicalTrials.gov NCT06058637. Registered on 27 September 2023.

Web-based Telemonitoring of Visual Function and Self-reported Postoperative Outcomes in Cataract Care: an International Multicenter RCT.

PURPOSE: Comparing 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 cataract patients were randomized into two 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 4-6 week post-surgery 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 to conventional ETDRS 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 0.15±0.67 diopters), resulting in a poorer corrected distance VA compared to subjective refraction (mean 0.1 vs. -0.1 logMAR). Rates of adverse events and unscheduled consultations were minimal across both groups. Preoperative and postoperative PROMs questionnaires had a 100% response rate. Visual functioning (Catquest-9SF and NEI-VFQ-25) improved after surgery (mean improvement -0.80 and 16.70 respectively) and did not significantly differ between the two groups. CONCLUSION: The cataract patients in this study effectively provided postoperative outcome data via 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.

Introducing e-health technology to routine cataract care: patient perspectives on web-based eye test for postoperative telemonitoring.

PURPOSE: To explore cataract patients' experiences with an e-health tool for self-assessing visual function (ie, a web-based eye test), and to formulate recommendations for its successful adoption in routine cataract care. SETTING: Clinics in the Netherlands, Germany, and Austria. DESIGN: Mixed-methods study. METHODS: 22 participants were included in this study; in-depth interviews were conducted with 12. Questionnaires and in-depth semi-structured interviews were conducted alongside a multicenter randomized controlled trial evaluating the validity, safety and cost-effectiveness of remote care after cataract surgery (Cataract Online Refraction Evaluation, a Randomized Controlled Trial). Results were analyzed thematically. RESULTS: Participants reported positively about performing the web-based eye test at home. 4 overarching themes were identified in the interviews. First, participants were inventive in overcoming practical barriers encountered while conducting the test. Second, participants desired a clear presentation of test results and their meaning. Third, the ability to self-monitor visual function was appreciated. Fourth, most participants preferred to keep the option to contact their eyecare professional (ECP) postoperatively, especially when experiencing symptoms. Most would be satisfied with a phone consultation or an e-consult. Participants reported positive experiences with the web-based eye test. Barriers for successful adoption were identified, including insecurity about correctly performing the test, incomplete information on how to interpret test results, and a feeling that in-hospital assessments were superior to remote assessments. CONCLUSIONS: It is recommended to focus on building trust in remote eyecare delivery and that access to the ECP be retained when medically indicated or deemed necessary by the patient.

Establishing a Biomarker for the Prediction of Short-Term Graft Detachment After Descemet Membrane Endothelial Keratoplasty.

PURPOSE: The purpose of this study was to investigate the predictive value of pachymetry mapping 1 day after Descemet membrane endothelial keratoplasty (DMEK) as a biomarker for early graft detachment. METHODS: This was a post hoc analysis of 65 pseudophakic subjects with Fuchs endothelial dystrophy who underwent DMEK surgery between December 2018 and April 2021 as part of the Advanced Visualization In Corneal Surgery Evaluation international multicenter randomized controlled trial. One eye per patient was included. Preoperatively and 1 day postoperatively, patients underwent anterior segment optical coherence tomography imaging. Using a grid consisting of 25 zones (ie, pachymetry map), corneal thickness and presence of a graft detachment were mapped for each patient. Detachments of any size were considered, regardless of subsequent clinical interventions. Missing data were imputed and subsequently divided into a training and test set. Two prediction methods were evaluated: one model based on absolute corneal thickness and a regression model. RESULTS: A total of 65 eyes were included for analysis of which 33 developed any form of graft detachment. Preoperatively, no significant differences were observed between the groups ( P = 0.221). Corneal thickness in the corneal zones with a detached graft was significantly increased compared with corneal zones with an attached graft ( P < 0.001). The regression prediction model had an area under the curve of 0.87 (sensitivity: 0.79 and specificity: 0.75), whereas the absolute thickness cutoff model only reached 0.65. CONCLUSIONS: Pachymetry mapping 1 day after DMEK was predictive for early graft detachment, and the prediction model had a good to excellent performance. This aids in identifying patients at risk for graft detachment and subsequent tailored postoperative care.

Evaluation of a visual acuity eHealth tool in patients with cataract.

PURPOSE: 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.

Video Grading of Descemet Membrane Endothelial Keratoplasty Surgery to Identify Surgeon Risk Factors for Graft Detachment and Rebubbling: A Post Hoc Observational Analysis of the Advanced Visualization In Corneal Surgery Evaluation Trial.

PURPOSE: The aim of this study was to explore video-graded intraoperative risk factors for graft detachment (GD) and rebubbling in Descemet membrane endothelial keratoplasty surgery. METHODS: A post hoc analysis of 65 eyes of 65 pseudophakic subjects with Fuchs endothelial dystrophy that underwent Descemet membrane endothelial keratoplasty surgery as part of the Advanced Visualization In Corneal Surgery Evaluation trial. All surgical recordings were assessed by 2 graders using a structured assessment form. A multinominal regression was performed to estimate the independent effect of video-graded intraoperative factors on the incidence of GD and rebubbling. Secondary outcomes are corrected distance visual acuity and endothelial cell density. RESULTS: In total, 33 GDs were recorded, of which 17 required rebubbling. No significant predictors for GD or rebubbling were identified. However, the results revealed 2 clinically relevant patterns. An unfavorable graft configuration (ie, wrinkled, tight scroll, or taco-shaped) and a gas-bubble size smaller than the graft diameter were associated with an increased risk of GD [odds ratio (OR) 2.5 and OR 2.26, respectively] and rebubbling (OR 2.0 and OR 2.60, respectively). Inversely, a larger gas-bubble size was associated with a reduced risk of GD (OR 0.37) and rebubbling (OR 0.36). At 3 and 6 months postoperatively, corrected distance visual acuity was poorer in subjects requiring a rebubbling and endothelial cell density loss was higher in subjects with a partial GD. CONCLUSIONS: Our analysis revealed that the gas-bubble size and graft shape/geometry seem to be relevant clinical factors for GD and rebubbling, whereas descemetorhexis difficulty, degree of graft manipulation, graft overlap, and surgical iridectomy were not associated with an increased risk.

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).

A Guide to Direct (Peri)ocular Injuries Caused by Snakes: Systematic Review and Treatment Advice.

Ocular injuries caused by snakes are very rare, but damage can be severe. There is little evidence on the effective treatment of these injuries. The aim of this systematic review is to discuss all available literature and summarize existing experiences in a treatment advice. In January 2022, a search was performed in the PubMed database. Penetrative trauma by venomous snakebites constitute the most severe cases, and can require the evisceration of the eye. Nonvenomous snakes, mostly boas and pythons held in captivity, are also able to perforate the eye, though with a more favorable disease course. Chemical trauma by inoculation of venom occurs as well, and copious irrigation is advised in these cases. Detailed suggestions for ophthalmologic treatment are presented.

Bilateral posterior lamellar corneal transplant surgery in an infant of 17 weeks old: Surgical challenges and the added value of intraoperative optical coherence tomography.

This study aimed to describe the surgical challenges, management, and value of intraoperative optical coherence tomography in a case of a bilateral Descemet Stripping Automated Endothelial Keratoplasty corneal transplantation at 17 weeks of age for the treatment of severe posterior polymorphous corneal dystrophy resulting from a de novo mutation of the OVOL2-gene.

Nationwide epidemiological approach to identify associations between keratoconus and immune-mediated diseases.

BACKGROUND: The aetiology of keratoconus (KC) remains poorly understood. KC has typically been described as a non-inflammatory disorder of the cornea. Nonetheless, there is increasing presumptive evidence for the role of the immune system in the pathogenesis of KC. AIM: To evaluate the association between KC and immune-mediated diseases on a population level. We hypothesise that KC is immune-mediated rather than a predominantly degenerative disease. METHODS: Data were obtained from the largest health insurance provider in the Netherlands. Dutch residents are obligatorily insured. The data contained all medical claims and sociodemographic characteristics from all KC patients plus all those data from a 1:6 age-matched and sex-matched control group. The primary outcome was the association between KC and immune-mediated diseases, as assessed by conditional logistic regression. RESULTS: Based on our analysis of 2051 KC cases and 12 306 matched controls, we identified novel associations between KC and Hashimoto's thyroiditis (OR=2.89; 95% CI: 1.41 to 5.94) and inflammatory skin conditions (OR=2.20; 95% CI: 1.37 to 3.53). We confirmed known associations between KC and atopic conditions, including allergic rash (OR=3.00; 95% CI: 1.03 to 8.79), asthma and bronchial hyperresponsiveness (OR=2.51; 95% CI: 1.63 to 3.84), and allergic rhinitis (OR=2.20; 95% CI: 1.39 to 3.49). CONCLUSION: Keratoconus appears positively associated with multiple immune-mediated diseases, which provides a population-based argument that systemic inflammatory responses may influence its onset. The identification of these particular diseases might shed light on potential comparable pathways through which this proinflammatory state is achieved, paving the way for pharmacological treatment strategies.