TRPP2 is located in the primary cilia of human non-pigmented ciliary epithelial cells.

PURPOSE: Mechanosensitive channels (MSCs) and primary cilium possess a possible relevance for the sensation of intraocular pressure (IOP). However, there is only limited data on their expression and localization in the ciliary body epithelium (CBE). The purpose of this study was to characterize the expression and localization of TRPP2 in a human non-pigmented ciliary epithelial cell (HNPCE) line. METHODS: The expression of the TRPP2 was studied by quantitative (q)RT-PCR and in situ hybridization in rat and human tissue. Protein expression and distribution were studied by western blot analysis, immunohistochemistry, and immunoelectron microscopy. Cellular location of TRPP2 was determined in rat and human CBE by immunofluorescence and immunoblot analysis. Electron microscopy studies were conducted to evaluate where and with substructure TRPP2 is localized in the HNPCE cell line. RESULTS: The expression of TRPP2 in rat and human non-pigmented ciliary epithelium was detected. TRPP2 was mainly located in nuclei, but also showed a punctate distribution pattern in the cytoplasm of HNPCE of the tissue and the cell line. In HNPCE cell culture, primary cilia did exhibit different length following serum starvation and hydrostatic pressure. TRPP2 was found to be colocalized with these cilia in HNPCE cells. CONCLUSION: The expression of TRPP2 and the primary cilium in the CB may indicate a possible role, such as the sensing of hydrostatic pressure, for the regulation of IOP. Functional studies via patch clamp or pharmacological intervention have yet to clarify the relevance for the physiological situation or aqueous humor regulation.

Introducing a customized low-cost macular buckle.

PURPOSE: To demonstrate a novel surgical technique that is a low-cost alternative to commercial implants for macular buckling in high myopia. METHODS: A silicon encircling band serves as the anchor. A second silicon circling band is employed, with a 10mm silicon strip to widen the posterior scleral indentation. This band is inserted posteriorly the lateral and inferior rectus muscles and pushed behind the globe, orienting it in a superior-temporal to inferio-nasal position with the silicone strip directly under the macula. For better visualization, the placement of the macular buckle is done under the microscope. RESULTS: The placement of the macular buckle led to reattachment of the central retina in treated patients during long-term follow-up. This technique eliminates the need for detaching a rectus muscle. Visual acuity remained stable throughout the follow-up period. CONCLUSION: This customized macular buckle technique can improve the anatomical outcome in patients with central retinal detachment due to high myopia.

Postoperative RNFL-Changes after Successful Trabeculectomy: 2-Year Outcomes. / Zwei-Jahres-Ergebnisse postoperativer RNFL-Entwicklung nach erfolgreicher Trabekulektomie.

BACKGROUND: The most important tool in glaucoma therapy is to lower the intraocular pressure to slow down the apoptosis of retinal ganglion cells. Trabeculectomy (TE) is considered the gold standard in glaucoma surgery. The aim of this study was to analyse the postoperative changes in retinal nerve fibre layer (RNFL) using optical coherence tomography (OCT) after TE. MATERIAL AND METHODS: We examined 40 patients naïve to prior glaucoma surgery retrospectively, who received a TE for medically uncontrolled primary open-angle glaucoma (POAG). Intraocular pressure (IOP), IOP-lowering medication, mean deviation of perimetry, visual acuity and peripapillary RNFL-thickness using OCT were evaluated during the first 24 month after TE. RESULTS: In total 40 eyes from 40 patients were treated with TE. Mean IOP decreased from 25.0 ± 0,9 to 13.9 ± 0.6 (p < 0.01), and the mean number of IOP-lowering eye drops from 3.3 ± 0.2 to 0.5 ± 0.2 (p < 0.01). Visual acuity and mean deviation in perimetry remained stable while mean global RNFL-thickness decreased from 67.8 ± 2.9 to 63.7 ± 2.9 (p < 0.01) and 63.4 ± 2.9 µm (p < 0.01) 12 and 24 months after TE. CONCLUSION: The TE is an effective method to reduce the IOD and the amount of IOP-lowering medication. Nevertheless, a significant further loss in RNFL thickness was observed in the first 12 months after TE. Thus, RNFL changes seem to stabilise only after a protracted period.

Legal obligation in the general population: face mask influence on endophthalmitis after intravitreal injection.

PURPOSE: To investigate whether compulsory face masking in public life changes the incidence or pattern of post-injection endophthalmitis (PIE). PATIENTS AND METHODS: All injections of bevacizumab, ranibizumab, aflibercept, dexamethasone or triamcinolone between 01/01/2015 and 12/31/2021 at the University Eye Clinic of Tuebingen were included in this retrospective analysis. The injection procedure itself was unchanged since 2015 and included the use of a sterile drape covering the head up to the shoulders which prevents airflow toward the eye. Furthermore, all staff wore a face mask and gloves at all times. The two study periods were defined by the introduction of a compulsory face masking rule in public life (01/01/2015 until 04/27/2020 vs. 04/28/2020 until 12/31/2021). RESULTS: A total of 83,543 injections were performed in the tertiary eye clinic, associated with a total of 20 PIE (0.024%, 1/4177 injections). Of these, thirteen PIE were documented during the pre-pandemic period (0.021%, 1/4773 injections) and seven PIE during the pandemic period (0.033%, 1/3071 injections). No significant difference in PIE risk was observed (p = 0.49), and there was no case of oral flora associated PIE. CONCLUSION: Although some potential confounders (wearing time, skin flora) could not be considered, there was no clear signal that the introduction of compulsory face masking in public life did alter the risk for PIE in our patient population. Three and six months after PIE, no difference in visual acuity was detectable between the two study periods.

Normative data for macular and retinal nerve fibre layer thickness in healthy German children and adolescents using optical coherence tomography.

PURPOSE: To establish normative data for macular thickness, macular volume and peripapillary retinal nerve fibre layer (RNFL) thickness using Spectralis® spectral-domain optical coherence tomography (SD-OCT) in healthy German children and adolescents and investigate influencing factors. METHODS: The cross-sectional study included the right eye of 695 children with at least one complete retinal OCT scan. As part of the LIFE Child study, the children underwent an ophthalmological examination including axial length (AL), spherical equivalent (SE) and OCT measurements. Various questionnaires were answered by the children or their parents to identify media use or outdoor time. Multiple linear regression models were used to investigate the potential influencing factors. RESULTS: A total of 342 boys and 353 girls with an average age (SD) of 12.91 (3.29) years participated. The mean AL (SD) was 23.20 (0.86) mm. The mean macular thickness (SD) was 320.53 (12.29) µm and the mean RNFL thickness (SD) was 102.88 (8.79) µm. Statistical analysis revealed a significant correlation between average macular thickness and age (p < 0.001, ß = 0.77) as well as AL (p < 0.001, ß = -4.06). In addition, boys had thicker maculae (p < 0.001, ß = 5.36). The RNFL thickness showed no significant correlation with children's age (p > 0.05), but with AL (p = 0.002, ß = -2.15), birth weight (p = 0.02, ß = 0.003) and a gender-specific effect of the body mass index standard deviation score for male participants (p = 0.02, ß = 1.93). CONCLUSION: This study provides normative data and correlations between macular and RNFL thickness in healthy German children. Especially age, gender and AL must be taken into account when evaluating quantitative OCT measurements to classify them as normal.

Surgical Care in Specialist Ophthalmology Departments: Structure and Impact of the COVID-19 Pandemic.

BACKGROUND: Specialist ophthalmology departments contribute to the surgical care of German patients. Outpatient and inpatient surgeries were restricted during the COVID-19 pandemic and led to a sharp decline in the number of cases in ophthalmological care. The aim of this analysis was to improve the understanding of the logistic structures of medical facilities as well as the effects of the pandemic. MATERIAL AND METHOD: Based on reported process data, a sample of the specialist ophthalmological departments were examined based on operation and procedure codes (OPS) and data submitted between 01.01.2017 and 31.05.2021 according to the benchmarking programmes of the Professional Association of German Anaesthetists (BDA), the Professional Association of German Surgeons (BDC), and the Association for Operating Theatre Management (VOPM). RESULTS: Eighteen ophthalmology departments from Germany were analysed. After the decline in the number of cases (by temporarily up to 48%) during the first wave of the pandemic, the case numbers of all interventions assessed as nonurgent continued to be reduced. While intravitreal injections hardly decreased during the first wave (- 16%), significant drops in the coverage of cataract surgery (- 79%), vitrectomies (- 35%), glaucoma surgery (- 59%), strabismus surgery (- 95%), and eyelid surgery (- 52%) were found. One exception was intravitreal injection, which stabilised at a lower level early on during the pandemic. Overall, the number of cases during the later phases of the pandemic were significantly reduced below the level of previous years, despite the maintenance of emergency care. The underuse was variable for different interventions. CONCLUSION: In addition to self-reported figures, the analysed process data demonstrates the effect that various factors had on elective as well as urgent operations within hospital care during the pandemic. Despite partial stabilisation of some services, a relevant supply gap for outpatient and inpatient interventions was identified, with corresponding effects on the eye health of the population, while compensation or performance enhancement have not taken place to date. Facing the growing preload and the demographic development, future structures must therefore allow for an increase in the performance of specialist ophthalmological departments.

Current Practice in the Treatment of Epithelial and Melanocytic Tumours with Interferon-α2b: A Survey of Tertiary Eye Centres in Germany.

PURPOSE: To evaluate the standard of care, in particular the use of topical or subconjunctival interferon-α2b, in treating ocular surface squamous neoplasia or melanocytic tumours in tertiary eye centres in Germany. METHODS: A survey containing 14 questions was sent to 43 tertiary eye centres in Germany. The questions addressed the surgical and medical management of ocular surface squamous neoplasia and melanocytic tumours (primary acquired melanosis and malignant melanoma), as well as the clinical experiences and difficulties in prescribing off-label interferon-α2b eye drops and subconjunctival injections. RESULTS: Twenty-four tertiary eye centres responded to the survey. Eighty-three percent of centres had used interferon-α2b in their clinical practice and 25% prescribed it as the first-line cytostatic agent following surgical excision of ocular surface squamous neoplasia, while 10% would do so for melanocytic tumours. Correspondingly, the majority of respondents selected mitomycin C as their first-line agent. Side effects were uncommon with topical interferon-α2b eye drops but were more frequently reported after subconjunctival interferon-α2b injections. In total, eight centres had experience with interferon-α2b injections. The most significant obstacles perceived by ophthalmologists when prescribing interferon-α2b were its high cost and the reimbursement thereof. CONCLUSION: Off-label mitomycin C was the preferred adjuvant therapy for epithelial and melanocytic tumours, with interferon-α2b being the standard second-line option. Interferon-α2b has predominantly been used to treat ocular surface squamous neoplasia and, to a lesser extent, melanocytic tumours at German tertiary eye centres. Following its market withdrawal, supply shortages of interferon-α2b are likely to have a profound impact on patient care and their quality of life.

Results of different strategies to manage complicated retinal re-detachment.

PURPOSE: Complicated retinal re-detachment with inferior proliferative vitreoretinopathy (PVR) remains a challenge. This study's aim was to compare vitrectomy with conventional silicon oil (CSO) combined with an encircling band (EB) and vitrectomy with heavy silicon oil (HSO) alone to treat retinal re-detachment through inferior PVR, where standard procedures have already failed. METHODS: A retrospective analysis was done on patients with inferior complex re-detachment with secondary PVR after primary surgery, who received pars plana vitrectomy (PPV) with CSO combined with EB (group 1) or PPV alone with HSO (group 2) between December 2006 and August 2017. The primary endpoint was retinal reattachment, and the secondary endpoint was visual acuity (VA) change and complications in both groups. RESULTS: This study included 119 eyes. Total single surgery anatomical success (SSAS) was 64%, with 80% (52/65) achieved in group 1 and 44.5% (24/54) in group 2 (p < 0.0001). The total final anatomical success (FAS) rate was 79% (94/119). In group 1, FAS was 91% (59/65) compared with 65% (35/54) in group 2 (p = 0.003). The pretreatment VA of group 1 had a median of 1.4 logMAR (95% CI 0.3-1.8), and group 2 showed a median of 1.4 logMAR (95% CI 0.2-1.8). The post-treatment decrease in group 1 was a median equal to - 0.6 versus - 0.1 for group 2 (p = 0.0001). Serious complications were similar in both groups. CONCLUSION: For complicated retinal re-detachment through inferior PVR, the combination of PPV with EB may lead to better anatomical (SSAS, FAS) and functional success compared with PPV alone with HSO.

Systematic review: non-adherence and non-persistence in intravitreal treatment.

PURPOSE: Intravitreal injection of VEGF inhibitors has become the standard of care for different macular diseases within the last years resulting in improved visual outcomes. Under real-life conditions, however, the necessity for frequent retreatments and reexaminations poses a burden for patients and treatment centers. Non-adherence and non-persistence to intravitreal treatment may lead to inferior clinical outcomes, and knowledge of contributing factors is crucial to improve adherence. This systematic review analyzes current literature for potential factors involved in non-adherence and non-persistence. METHODS: A systematic search was conducted in PubMed and Embase including three different aspects of intravitreal injection therapy: (1) diseases with intravitreal injections as treatment, (2) intravitreal injection, and (3) aspects of therapy adherence or therapy persistence. Data from identified quantitative studies were further extracted and grouped according to WHO criteria (condition, socio-economy, therapy, patient, and health system). The methodological quality of identified studies was graded. Identified qualitative studies (i.e., interviews) were descriptively analyzed and their findings narratively reported. RESULTS: Twenty-four publications were included. In 16 of those publications, a quantitative data analysis was conducted, analyzing factors associated with non-adherence. Worse visual acuity at baseline and unfavorable development of visual acuity, higher age, and greater distance to the treatment center were associated with non-adherence, while there was inconsistent evidence for an association of comorbidity. In qualitative studies, high follow-up/treatment burden, fear and anxiety, disappointed patient expectations, and lack of motivation to continue treatment were reported as reasons for non-persistence. CONCLUSIONS: Knowledge of potential barriers in IVT treatment may improve adherence and potentially clinical results. Improvements can be achieved particularly in the healthcare complex (organizational improvements) and the "patient" complex by establishing realistic expectations. Recurrent education of the patient may be necessary.

Correction to: Visual impairment and blindness in institutionalized elderly in Germany.

The original version of this article inadvertently contained a mistake. Authors incorrectly listed in PDF version while correctly presented in the html version.

Visual impairment and blindness in institutionalized elderly in Germany.

PURPOSE: To determine the prevalence of and identify factors associated with visual impairment and blindness in institutionalized elderly in Germany. METHODS: In this prospective multicenter cross-sectional study, ophthalmic health care need and provision were investigated in institutionalized elderly in 32 nursing homes in Germany. All participants underwent a standardized examination including medical and ocular history, refraction, visual acuity testing, tonometry, biomicroscopy, and dilated funduscopy. A standardized questionnaire was used to identify factors associated with eye healthcare utilization, visual impairment and/or blindness. RESULTS: Visual acuity of 566 (94.3%; 413 women and 153 men) of a total of 600 institutionalized elderly was determined. Mean age of the included patients was 82.9 years (± 9.8). Of all participants, 30 (5.3%; 95% CI 3.4-7.2%) were blind and 106 (18.7%; 95% CI 15.5-21.9%) were moderately or severely visually impaired according to the World Health Organization definition. The 136 blind and moderately or severely visually impaired participants were older (OR, Odds Ratio = 1.1, 95% CI 1.0-1.1; p < 0.001), and more likely to have reduced mobility (OR = 12.6, 95% CI 2.8-57.6; p = 0.001). CONCLUSION: A high proportion of blindness and visual impairment was found amongst nursing home residents. Age and reduced mobility were factors associated with an increased likelihood of blindness and visual impairment. Any surveys of blindness and visual impairment excluding nursing homes may considerably underestimate the prevalence of visual impairment and blindness.

PROSPECTIVE RANDOMIZED TRIAL ASSESSING THE IMPACT OF FEEDBACK MECHANISMS ON PATIENT POSITIONING.

PURPOSE: To investigate the use of a head-fixed feedback sensor to improve good positioning times after macular hole or retinal detachment surgery. The instructional methods, macular hole closure rates, and questionnaire responses were also evaluated. METHODS: After randomization, sensor devices with different feedback types (none/acoustic/vibration) were fixed on the patients' heads. Two positioning recommendations (verbal/illustrated) were used. The posturing data were logged every 500 ms for 24 hours. RESULTS: Forty-eight data sets (24 per group) were evaluated. Using sensory feedback, the median time for face-down positioning after macular hole surgery (Group 1) was significantly boosted from 463 minutes (range: 61-1,168) to 1,257 minutes (range: 1,024-1,327). The side positioning time after retinal detachment surgery (Group 2) increased from a median of 1,032 minutes (range: 520-1,165) to 1,284 minutes (range: 1,231-1,437). The night-time alarm records were reduced; however, the instructional methods exhibited no noteworthy effects. The questionnaires indicated positive acceptance of the sensors. CONCLUSION: Sensory feedback may help in cases where face-down or side positioning is recommended. These constant reminders were superior to verbal or written reminders; however, further studies are required to assess the clinical impact of sensory feedback on patient positioning.

New digital methods: remodelling the harms tangent scale setting.

PURPOSE: The aim of this study is to present a feasibility study to evaluate and compare a self-constructed, digital-based tangent scale using the Harms tangent screen test for the examination of patients' strabismus angles. METHODS: The documented strabismus angles of 10 patients were measured at nine gaze-positions and compared using the Harms tangent screen test (Harms Screen) and a self-constructed digital screen test (Digital Screen). The primary outcome is the difference in the measured angles between both methods. Secondary outcomes include the duration of the examinations and the diagnostic conclusion based on the results of the measurements. RESULTS: The datasets from 10 of 13 patients were used for comparisons (median age 52 years; females 5; males 5). All measurements showed a mean of 1.77° (SD 2.95°) in horizontal deviations and 1.11° (SD 2.23°) in vertical deviations. The two methods showed differences (> 5°) in 12 cases (13.3%) for horizontal angle measurements and in four cases (4.4%) for vertical angle measurements. The median examination time was 238 s (range 60-430 s) for the Harms Screen and 150 s (range 120-600 s) for the Digital Screen tests. The diagnostic conclusions were identical for both methods. CONCLUSIONS: The feasibility of the experimental digital setup in principle is shown. Despite some deviations in the measured strabismus angles, the resulting diagnosis of the paresis was identical. The new method showed a reduction of examination time.

Design and Baseline Characteristics of the HELP Study: An Extended and Long-Term Observation of Pathological Myopia in Caucasians.

PURPOSE: To assess the natural disease progression of high myopia in Caucasians considered at risk for the development of myopic choroidal neovascularization (mCNV). METHODS: Subjects were recruited in 25 clinical sites between June 2014 and June 2016. Main inclusion criteria included axial length of ≥26 mm, best-corrected visual acuity ≥0.05 decimal equivalent and presence of at least one out of five predefined morphological disease risk criteria. These were (1) subfoveal choroidal thinning < 50 µm, (2) enhanced choroidal curvature length > 6,300 µm, (3) lacquer cracks, (4) patchy atrophy > 5 mm2 and (5) preexisting mCNV in the fellow eye (German Clinical Trial Register DRKS00007761). RESULTS: A total of 150 participants (66% females) with a mean age of 57.2 (±12.7) years (range 21.9-86.2 years) were included. The disease criteria most frequently encountered were choroidal thinning (33.3%) and lacquer cracks (32.7%). Enhanced choroidal curvature length was detected in only 8 subjects and always occurred in combination with other disease criteria. Presence of patchy atrophy was found to be more common in older subjects (p = 0.0012) and also associated with a more severe disease manifestation. CONCLUSION: The baseline data of this study indicate that enhanced choroidal curvature might be less common in Caucasians than in Asian populations. Further, disease severity in patients with high myopia is relatively high in the presence of patchy atrophy.

Patients' preferences for involvement in the decision-making process for treating diabetic retinopathy.

BACKGROUND: To assess factors associated with the preferred role of the attending ophthalmologist in the decision-making processes before treating diabetic retinopathy (DR). METHODS: Cross-sectional study of 810 adults attending secondary diabetes care centers (NCT02311504). Diabetes patients were classified using a validated questionnaire in an ophthalmologist-dominant decision-making (ODM), shared decision-making (SDM) and patient-dominant decision-making (PDM) style. Multivariate logistic regression was performed to determine factors associated with the decision-making process. RESULTS: A majority of 74.3% patients preferred SDM between ophthalmologist and patient, 17.4% patients wanted ODM, delegating the decision-making process to the ophthalmologist, 8.3% preferred the autonomous style of PDM. Patients wanting ODM were older (OR = 1.2 per decade, p = 0.013), had a lower level of education (OR = 1.4, p = 0.001) and had a higher frequency of consultations per year (OR = 1.3, p = 0.022). Patients with better basic knowledge in DR and memorizing their HbA1c level showed a higher propensity for SDM (OR = 1.1, p = 0.037). Patients wanting PDM had a significantly higher education (OR = 1.3, p = 0.036) and a greater desire for receiving information from self-help groups (OR = 1.3, p = 0.015). CONCLUSIONS: The first evaluation of the general patient wishes for the treatment of DR confirmed the concept of SDM, which was favored by three quarters. In particular, older patients with low educational attainment wanted to delegate the decision-making process to the ophthalmologist. Amelioration of ophthalmologic education in diabetic programs might take up patients' propensity for SDM. Regardless of the decision-making group, nearly all patients wanted the medical and scientific information to be transferred by and shared with the ophthalmologist. TRIAL REGISTRATION: The study was registered on www.clinicaltrials.gov (identifier: NCT02311504) on December 4th 2014.

[Healthcare Research into Anti-VEGF Therapy: Selection and Methodological Precautions]. / Versorgungsforschung der Anti-VEGF-Therapie: Selektion und methodische Besonderheiten.

Health care research has emerged as an approach to assess and improve quality of care and patient outcomes in the real world. It also has the potential to reduce healthcare costs by providing evidence to guide healthcare decisions.Randomised controlled trials (RCTs) theoretically offer the ideal study design to support treatment decisions. In RCTs, randomisation (formal chance) determines treatment allocation, which prevents selection bias from distorting the parameters of anti-VEGF treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in neovascular age-related macular degeneration or diabetic macular oedema trials, which limits the validity of the results to the whole patient population seen in clinical practice. The evidence base for anti-VEGF is deficient in terms of matching the characteristics of patients encountered in clinical practice, and a more representative sample of older people and those with significant disability must be included in future trials. RCTs often do not address other knowledge gaps, including treatment delay, comparisons for less frequent types of CNV, monitoring of rare or late toxicity events or systemic safety.Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomisation, can complement RCTs by providing data that is more relevant to the circumstances under which intravitreal therapy is routinely practiced. However, it is important to be aware of the strengths and limitations of such observational study designs, in order to optimise the design as well as the analytic techniques. Selection bias and loss-to-follow-up cause make comprehensive interpretation and careful analysis necessary. Future reports should focus on time-to-event analysis, as this is much less prone to loss-to-follow-up and improves adherence of (functionally) one-eyed or good responders. Observational studies and pragmatic trials can test new hypotheses and possible license extensions. The bearing of RCT findings on day-to-day practice can then be assessed. The data can be interpreted in a more meaningful manner by practicing clinicians if evidence is integrated from a variety of different study designs and methodologies.

Ex-vivo-examination of ultrastructural changes in organotypic retina culture using near-infrared imaging and optical coherence tomography.

Optical coherence tomography (OCT) dramatically changed the way of diagnostic assessment in retinal diseases during the last years. Using this technique in-vivo in-depth analysis of the retina and its layers is possible. Since animal research is changing by intrinsic and extrinsic pressure to animal-(in-vivo)-free methods, we adapted OCT-measurements to organotypic cultures. An easy to use protocol was generated to assess standardized OCT assessments in organotypic culture. First, two custom-made devices need to be made to change any commercially available OCT for examinations in humans into a device allowing ex-vivo analyses of organotypic culture. The modification is feasible within seconds. After OCT measurement of the ex-vivo tissues, quantitative evaluation of the retinas were performed via ImageJ software. OCT pictures of ex-vivo retinas were obtained for time periods of seven days and the thickness of retinal tissue was evaluated. The reproducibility of the pictures and measurements was very high (SD < 15%). In conclusion, an easy to use protocol for the investigation of different effects on retinal cultures with commercially available OCT devices was successfully established.

Vision-related quality of life in patients receiving intravitreal ranibizumab injections in routine clinical practice: baseline data from the German OCEAN study.

BACKGROUND: Vision-related quality of life (vrQoL) is advancing more and more into the focus of interest in ophthalmological clinical research. However, to date only little information is available about vrQoL from large non-interventional studies in terms of "real-world evidence". The purpose of this investigation was to describe baseline VFQ-25 visual function scores, to evaluate whether they differ from previous phase III clinical trials, to determine which contributing factors (e.g. indication, age, gender) affect VFQ-25 scores and to identify its impact on driving. METHODS: The non-interventional OCEAN study (Observation of treatment patterns with LuCEntis and real life ophthalmic monitoring, including optional OCT in Approved iNdications) is the largest ophthalmic study conducted in Germany, to evaluate the real world situation of patients treated with ranibizumab (NCT02194803). The NEI-VFQ-25 questionnaire was conducted at baseline, months 4, 12 and 24. Descriptive statistics was used to analyse the baseline data. ANOVA was performed to evaluate the impact of various contributing factors on composite and selected subscale scores. RESULTS: Overall, 4844 (84.1 %) of all 5760 OCEAN patients completed the VFQ-25 questionnaire at baseline. Thereof, 3414 treatment-naïve patients were further analysed. Overall, the VFQ subscore general health was most affected by the ocular disease, followed by general vision. No major differences were detected in comparison to corresponding VFQ-25 scores of previous phase III clinical trials, except in DME patients, or with respect to possible contributing factors. A tendency towards a more decreased VFQ-25 composite score was observed for nAMD, for elderly patients ≥75 years of age, for female patients, for patients with low baseline visual acuity (VA; <50 letters) and for those with statutory health insurance. Indication, age, gender, baseline VA (all p <0.01) and the interaction of age and indication, as well as baseline VA and indication (p <0.01 each) had a significant impact on composite, general vision and distance vision scores (ANOVA). About 10 % of patients gave up driving due to eyesight issues. CONCLUSIONS: The knowledge of a patient's subjective disease burden is crucial to understanding anxieties and mental anguish. Additionally, the understanding of the impact of various contributing factors on the VFQ-25 scores and the extent to which they can be influenced help to optimize patient care. It demonstrates the need for medical and mental support by all medical staff, to encourage patients' compliance with a comprehensive anti-VEGF therapy, to increase BCVA and, consecutively, VFQ-25 scores. TRIAL REGISTRATION: NCT02194803.

Limited Time from the Diabetes Patients' Perspective: Need for Conversation with the Eye Specialist.

PURPOSE: Facing the lack of time, busy retina consultants should be aware of how the patients would prefer that time is spent and whether they wish the specialist to talk more at the expense of other medical activities. METHODS: 810 persons with diabetes were asked to divide the time of 10 min between examination, consultation and treatment when envisioning a real-life scenario of diabetic retinopathy (NCT02311504). RESULTS: With the increasing duration of diabetes, patients wanted significantly more time for diagnostics (p = 0.028), while age was found to be associated with less time for treatment (p = 0.009). Female subjects tended to prefer only little more time for talking (p = 0.051) in comparison with males, who slightly favored therapy (p = 0.025). CONCLUSIONS: The large majority recognized the need for diagnostics in their allocation of time. If individual patients are confronted with the health care perspective of time constraints, this might improve the understanding of prioritization.