Natural History of Visual Acuity and Microperimetry-Based Functional Outcome Measures of the Macula in Patients with Geographic Atrophy: A Retrospective Chart Review Study in Germany.

Background/Objectives: Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) leading to the progressive and irreversible loss of visual function. Characteristics of GA include atrophic lesions resulting from the loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. During GA progression, atrophic lesions typically advance from the macular periphery to the center, affecting foveal light sensitivity and visual acuity. This study analyzed changes in light sensitivity and visual acuity during the natural course of GA progression using the topographic analysis of structural and functional changes based on Early Treatment Diabetic Retinopathy Study (ETDRS) charts, multimodal imaging, and microperimetry assessment. Methods: Medical chart data of GA patients between 2014 and 2022 from the Internationale Innovative Ophthalmochirurgie GbR (I.I.O.) research center (Düsseldorf, Germany) were retrospectively analyzed. All patient eyes fulfilling the phase 3 OAKS study inclusion criteria were included and followed up for 60 months. The imputation of missing measurements and dropouts was performed by linear mixed models. Results: A total of 20 GA eyes from 13 GA patients were included in the study. At the index, 53.8% of patients had bilateral GA, with 70.0% of the eyes showing multifocal GA and 30.0% subfoveal encroachment (SFE). A total of 35.0% of the eyes had 2-5, and 15.0% over 20, areas of atrophy. Over time, the GA lesion size increased from 6.4 mm2 to 11.8 mm2 (1.08 mm2/year). After an average observation time of 2.9 years, 78.6% of the initially unaffected study eyes developed SFE. The percentage of study eyes without visual impairment decreased from 55.0% to 30.0%, with mean normal-luminance best-corrected visual acuity (NL-BCVA) reducing from 63.7 to 55.7 ETDRS letters. The share of absolute scotoma points in microperimetry assessment increased from 15.7% to 43.5% while overall average macular sensitivity declined from 15.7 dB to 7.4 dB. Conclusions: The substantial deterioration of macular outcomes and visual function was comprehensively detected. The results were a documentation of structural and functional aspects of the natural progression of GA for a 60-month follow-up, providing a typical outline for AMD patients with GA.

[Aflibercept in a real-world setting: the AURIGA study : 24-month results of the German cohort of treatment-naïve patients with macular edema following retinal vein occlusion receiving intravitreal aflibercept]. / Aflibercept im klinischen Alltag: die AURIGA-Studie : 24-Monats-Ergebnisse der deutschen Kohorte behandlungsnaiver Patienten mit Makulaödem bei retinalem Venenverschluss unter Therapie mit intravitrealem Aflibercept.

BACKGROUND: AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept 2 mg (IVT-AFL) treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) and diabetic macular edema. Here we present the 24-month data from the German cohort of treatment-naïve patients with ME due to RVO. METHODS: Treatment-naïve patients with ME secondary to RVO were treated with IVT-AFL 2 mg in the routine clinical practice. The primary endpoint was mean change in visual acuity (VA, early treatment diabetic retinopathy, ETDRS, letters) at month 12 compared to baseline. Analyses were descriptive. RESULTS: Analysis included 130 patients with RVO (n = 61, 46.9% with central RVO, n = 69, 53.1% with branch RVO). The mean (± SD) time the RVO patients remained in the study was 18.4 ± 7.4 months. The mean VA gain (95% confidence interval) in the overall cohort was +10.9 (7.5-14.2) letters at month 12 and +9.7 (6.1-13.3) at month 24 (baseline VA 56.5 ± 18.9 letters). At 24 months, 67% of RVO patients gained ≥5 letters and 40% gained ≥15 letters. The mean number of injections was 4.4 ± 1.3 up to month 6, 6.2 ± 2.7 up to month 12 and 8.2 ± 4.5 up to month 24. The mean central retinal thickness (CRT) reduction was -206µm (-252 to -160µm) at 12 months and -219µm (-263 to -175µm) at 24 months (baseline CRT 507 ± 177 µm). The safety profile was consistent with that of previous studies. DISCUSSION: In the German AURIGA cohort of treatment-naïve patients with ME secondary to RVO, IVT-AFL 2 mg treatment in clinical practice resulted in rapid and clinically relevant VA gains and a reduction in CRT. These results were largely maintained over 24 months despite the low injection frequency from month 6.

Customizing Clinical Outcomes with Implantation of Two Diffractive Trifocal IOLs of Identical Design but Differing Light Distributions to the Far, Intermediate and Near Foci.

Purpose: To evaluate clinical outcomes after bilateral or contralateral implantation of the Gemetric™ (G) and Gemetric™ Plus (GPlus) diffractive trifocal intraocular lenses (IOLs). Methods: This was a prospective, randomized, multi-center open-label study comparing clinical results and subjective patient responses around 6 months after implantation of the study lenses (toric and non-toric) in three different groups (bilateral G, bilateral GPlus and contralateral G/GPlus implantation). Results included the manifest refraction, uncorrected and distance corrected monocular and binocular visual acuity (VA) at distance, intermediate and near; the defocus curve; contrast sensitivity; and patient reported outcomes regarding spectacle independence, satisfaction and visual disturbances. Results: There was no statistically significant difference in the mean refraction spherical equivalent between the two lens models (p = 0.33) or between the toric and non-toric lenses (p = 0.06). Monocular VA was better at distance with the G lens and better at near with the GPlus lens (p < 0.01). Mean binocular VA was better than 0.1 logMAR at all distances for all groups, both uncorrected and distance corrected. The mean binocular distance corrected VA was better than 0.15 logMAR from 0.0 D to -3.50 D for all groups. All VA data for the contralateral group was as good or better than for the bilateral GPlus group. Questionnaire results showed no difference between groups for the frequency, severity, or degree of bother of visual disturbances (p > 0.24). Conclusion: The two diffractive trifocal IOLs studied here may be used either bilaterally or contralaterally for the correction of presbyopia in cataract patients, providing excellent visual acuity with low levels of visual disturbances and high rates of overall spectacle independence. Bilateral Gemetric implantation resulted in slightly better distance and intermediate vision while contralateral implantation provided slightly better near vision. There was no apparent advantage to implanting the GPlus IOL bilaterally.

Contrast Adaptation in Pseudophakic Patients with Macular Disorders.

PURPOSE: To learn whether contrast adaptation, induced by positive spherical defocus, is compromised by macular disorders such as age-related macular degeneration (AMD) or epiretinal membranes (ERM) and to gain further insight in the functionality of the pathological macula and the level of "functional reserve" often postulated for the indication of presbyopia correcting IOLs. METHODS: In a pilot study, patients with macular disorders, AMD and ERM, (n = 10) and healthy volunteers (n = 10) were tested to quantify contrast adaption after +4 D defocus for 10 min, by performing an interocular contrast matching task. Subjects manually adjusted the perceived contrast of the test patch as seen by the test eye to match to the contrast of a target patch with a fixed Michelson contrast of 0.2 as seen by the contralateral untreated eye. RESULTS: Patients with macular disorders subjectively matched the 0.2 target contrast with a contrast of 0.24 ± 0.06 (mean ± SD) before adaptation and with a contrast of 0.19 ± 0.04 after adaptation (p < 0.05). Accordingly, patients with macular disorders showed an induced contrast gain by adaptation of 0.05 (27%), which was not different from the control group, which showed an induced contrast gain by adaptation of 0.06 (35%). CONCLUSION: Patients with mild and moderate macular disorders, such as AMD and ERM, show an induced contrast adaptation, i.e. a gain in contrast sensitivity, at 3.2 cpd, which is not different in level from the induced contrast adaptation in healthy subjects. Macular disorders do not prevent adaptation of the patient's visual system to low contrast or blurred retinal images. Therefore, the implantation of presbyopia correcting IOLs is not a strict exclusion criterion for these patients, but the progressive nature of the macular disorder must be taken into account.

Preservatives and pH in low-dose atropine formulations for clinical trials.

Over a century ago, atropine has been tested to arrest myopia progression with good results. In recent years, many randomized clinical trials have tested different concentrations against placebo. Three recent such studies with low-dose atropine showed that it was less effective than previous studies, even the last one showing no difference in myopia progression between the treated and control group. Previous randomized studies had been performed in Asian populations, and these last three were extended to Western Caucasian populations, based on the initial observation that differences in iris pigmentation could be a factor for a difference in effectiveness. We have noticed that the three last studies in the West have used the same patented formulation, while previous studies have preferred compounded low-dose atropine. Here we review how the power of hydrogen (pH) and preservatives could account for differences in drug penetration to the eye, possibly explaining the differences between studies.

Age-matched analysis of axial length growth in myopic children wearing defocus incorporated multiple segments spectacle lenses.

BACKGROUND/AIMS: Defocus incorporated multiple segments (DIMS) spectacle lenses are known to be able to inhibit axial length (AL) growth in myopic children compared with single vision (SV) spectacle lenses. However, it is not known whether AL growth is sufficiently inhibited to achieve the treatment goal of physiological AL growth. METHODS: Of the data already collected in 2014-2017 by Lam et al, the AL growth with DIMS and SV spectacle lenses was re-evaluated according to the age-matched myopia control system. The individual AL growth after the first year of treatment of each eye was plotted against the corresponding age of the same time point in a colour-coded scheme. The two treatment groups were further subdivided based on their age and their baseline AL. RESULTS: Overall, 65% (61% of male, 70% of female) of eyes with DIMS spectacle lenses and 16% (16% of male, 16% of female) of eyes with SV spectacle lenses are within range of physiological AL growth rate. Median AL growth rate of eyes with DIMS spectacle lenses is also within the range of physiological growth. In the subgroups, eyes with DIMS spectacle lenses were also superior to the ones with SV spectacle lenses regarding this treatment goal. Of the children with SV spectacle lenses, older children and children with eyes with high baseline AL were least likely to achieve physiological AL growth rate. CONCLUSIONS: DIMS spectacle lenses can bring the AL growth rate of myopic children to the level of physiological AL growth rate, indicating 100% reduction of excessive myopic AL growth, independent of age and baseline AL. Older children and children with eyes with high AL have the risk to have increased AL growth without treatment.

Non-Invasive Treatment of Early Diabetic Macular Edema by Multiwavelength Photobiomodulation with the Valeda Light Delivery System.

Purpose: Diabetes is associated with ocular complications including diabetic macular edema (DME). Current therapies are invasive and include repeated intravitreal injections and laser therapy. Photobiomodulation (PBM) is a treatment (Tx) that utilizes selected wavelengths of light to induce cellular benefits including reduction of inflammation and edema. This single-center, open-label, post-hoc analysis explored the utility of multiwavelength PBM in subjects with DME. Methods: Analysis included review of data from patients undergoing standard clinical care with an approved and marketed PBM medical device, the Valeda® Light Delivery System. Subjects with early-stage DME with good vision (Best-corrected visual acuity (BCVA) > 20/25, logMAR > 0.1) were evaluated in clinic and treated with one series of multiwavelength PBM (Tx delivered 3x/week over 3-4 weeks; total of 9 Tx sessions). Clinical, anatomical, and safety parameters were assessed in addition to subjective quality of life. Results: A total of 30 eyes (19 subjects) were analyzed. Subjects were predominately male (68.4%) with a mean age of 56 ± 14 years. Reductions in central retinal thickness (CRT), resolution of intraretinal fluid (IRF) and improvement in diabetic retinopathy severity scale scores were observed following PBM treatment in select patients. Baseline BCVA remained stable over the follow-up observation period of 3 months post-PBM. Approximately 64% of patients reported subjective improvements in their ocular condition and decreased influence in everyday life. Detailed OCT evaluations confirmed no safety issues related to phototoxicity up to 16 months. Conclusion: Early-stage DME subjects treated with Valeda multiwavelength PBM showed improvements in clinical and anatomical parameters. The Valeda multiwavelength PBM approach demonstrates a favorable safety profile with no signs of phototoxicity following an independent OCT review. PBM therapy may offer an alternative, non-invasive treatment strategy with a unique mechanism and modality for patients with early-stage DME.

Prevalence of Geographic Atrophy in Advanced Age-Related Macular Degeneration (AMD) in Daily Practice.

PURPOSE: To investigate the prevalence of geographic atrophy (GA) in advanced age-related macular degeneration (AMD) and the proportion of eyes that would meet the indication criteria for treatment with the first intravitreal anti-C3 agent (pegcetacoplan). METHODS: This retrospective cross-sectional study included all AMD patients who visited the Macular-Retina-Centre Oberkassel in 2021. Eyes were classified according to AMD stages. Eyes with GA were divided into two groups regarding foveal involvement. Baseline factors were compared between eyes with foveal GA (FGA) and eyes with non-foveal GA (NFGA) to identify predictive factors for foveal involvement. RESULTS: A total of 2033 eyes from 1027 patients were included. AMD stage was early in 296 (14.5%) cases, intermediate in 368 (18.1%) cases, and advanced in 1249 (61.4%) cases. A total of 1204 (60%) eyes had GA [932 (77%) FGA and 272 (23%) NFGA], while 125 eyes (27.4% from eyes with advanced dry AMD) met the indication criteria for treatment with intravitreal pegcetacoplan. The proportion of eyes with neovascular AMD was significantly higher in the FGA group compared to the NFGA group [598 (64.2%) vs. 152 (55.8%), p = 0.01]. CONCLUSIONS: At least a quarter of eyes with advanced AMD would be suitable for the upcoming intravitreal pegcetacoplan therapy. Foveal involvement of GA in advanced AMD seems to be more likely in neovascular AMD than in dry AMD.

A Comparison of Optical Biometers Used in Children for Myopia Control.

PURPOSE: To assess the reproducibility (i.e., inter-device reliability) of the biometers Topcon MYAH, Oculus Myopia Master, and Haag-Streit Lenstar LS900 with the Carl Zeiss IOLMaster 700 and the intra-subject repeatability in myopic children in order to reliably detect axial growth for myopia management. METHODS: Twenty-two myopic children (11.1 ± 2.4 yr) with a spherical equivalent of - 3.53 ± 2.35 D were examined with each of the biometers to assess axial length (AL) and corneal parameters (steepK, flatK, meanK, vectors J0, J45), and16 of these children agreed to a second round of measurements. Reproducibility of the first measurements between the IOLMaster and every other biometer was assessed employing a Bland-Altman approach and paired Student's t-test. Repeatability was assessed as intra-subject standard deviation and was used to estimate the minimum time interval required between two AL measurements to reliably detect axial growth of an eye of at least 0.1 mm/year. RESULTS: Repeatability for AL measurements was as follows: IOLMaster: 0.05 mm, Myopia Master: 0.06 mm, Myah: 0.06 mm, Lenstar: 0.04 mm; the respective minimal time interval for axial growth assessment in myopia management was estimated as 5.6, 6.6, 6.7, and 5.0 months, respectively. Best reproducibility of the AL measurement was found between IOLMaster and Lenstar [95% Limits of Agreement (LoA) for reproducibility - 0.06 to 0.02]. As regards to the measured means, Lenstar gave measures of AL that were longer than with the IOLMaster by 0.02 mm (p < 0.001). Myopia Master measures of meanK were significantly lower (by 0.21 D with p < 0.001) than the values from the IOLMaster. As for J0, all biometers deviated significantly from IOLMaster measurements (p < 0.05). CONCLUSION: Generally good agreement was observed between all the biometers. When assessing myopia progression in children, a time frame of at least 6 months between the AL measurements is advisable in order to reliably determine any deviation from a normal growth pattern.

[Post-SMILE-What myopes know about their secondary emmetropic eyes]. / Post-SMILE ­ Was Myope über ihre sekundär emmetropen Augen wissen.

BACKGROUND: Small incision lenticule extraction (SMILE) is popular among young myopic adults for long-term correction of myopia; however, the excessive axial lengths of myopic eyes and the associated risks for more serious eye diseases later on remain with surgical correction of the refractive error. These risks are greater the higher the myopia is. Are patients well informed about this and to what extent does further eye growth occur even after SMILE? MATERIAL AND METHODS: Myopic young adults who underwent binocular SMILE before 2019 were given the opportunity to have their eyes examined at a follow-up visit (biometry using IOL-Master 700 [Zeiss, Oberkochen, Germany], subjective refraction, examination of the anterior and posterior segments of the eye using the slit lamp) and to participate in a survey. Patients with a preoperative axial length ≥ 25.5 mm and a preoperative axial length < 25.5 mm (high myopia) were statistically evaluated separately. RESULTS: A total of 44 patients (age 30.39 ± 2.39 years) appeared at the visit and the SMILE was 3.18 ± 0.82 years ago: The spherical equivalent at the follow-up visit was -0.05 ± 0.21 dpt in the weaker myopes and -0.18 ± 0.23 dpt in the high myopes. Of the respondents 27% estimated that SMILE would reduce the risk of retinal detachment and cataract, with 80% of high myopes underestimating the individual risk of retinal detachment. Also, 57% said they would not see an ophthalmologist until within 1 week if they had symptoms consistent with acute retinal detachment, and only 27% would go to an emergency room immediately. In general, 59% reported having normal health awareness and 41% reported going for annual ophthalmological check-ups. CONCLUSION: The collected axial lengths and refractions show no relevant change in the eyes regarding progression of myopia; however, the patients' statements in the survey point out that most patients are not aware of the risk of serious eye diseases (retinal detachment, cataract). Therefore, repeated risk education and close postoperative care are needed, especially in preoperatively highly myopic patients.

Safety of DIMS Spectacle Lenses and Atropine as Combination Therapy for Myopia Progression. / Sicherheit von Brillengläsern mit DIMS-Technologie und Atropin in der Kombinationstherapie der Myopieprogression.

BACKGROUND: The aim of this study was to evaluate traffic safety of Defocus Incorporated Multiple Segments (DIMS) spectacle lenses in combination therapy with atropine. PATIENTS AND METHODS: 12 young adults (age: 24 - 45; 30,1 ± 5,7 years) were recruited to evaluate corrected distance visual acuity (CDVA), contrast sensitivity (CS; FrACT), glare sensitivity (Mesotest) under the influence of DIMS spectacle correction alone and combination therapy with 0,01% atropine. RESULTS: When looking through the central area of the DIMS lens, far vision does not decrease due to the influence of atropine; influence of glare and atropine leads to a reduction of CDVA by 0.10 logMAR. When forced to look through the DIMS area, far vision is reduced by 0.09 logMAR due to the influence of atropine in the absence of glare; in the presence of glare, no further loss of visual acuity can be observed under the influence of atropine. Contrast vision with DIMS glasses is not altered by the effects of atropine. Concerning glare sensitivity, DIMS lenses did not show any visual impairment that would be relevant to vision and road safety. Additional atropinization does not affect glare sensitivity. CONCLUSION: DIMS spectacle lenses are safe for participation in road traffic and do not relevantly impair traffic safety, neither alone nor under the acute influence of 0,01% atropine.

Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study.

Objective: Visual performance and short-term tolerability of different designs of myopia correcting options, including therapeutically relevant bifocal contact lenses (CL) and spectacle lenses with 'defocus incorporated multiple segments (DIMS)' technology were compared. Methods and analysis: In myopic volunteering subjects (n=8; spherical equivalent range: -1 to -7 D) visual acuity (VA) using Landolt C and contrast sensitivity (CS) using contrast C were assessed at three different gaze positions (-22° nasal, +22° temporal and 0° central), corresponding to a gaze through the DIMS area or the clear area of the DIMS lens design, respectively, after short-term wear of each of single vision spectacle lenses (SV), DIMS spectacle lenses (DIMS), monofocal soft CL and centre-near multifocal soft CL (MCL). Also, CS was assessed under photopic and mesopic light conditions with and without glare using sinusoidal gratings at 1.5, 3, 6, 12 and 18 cpd. Results: Mean VA (Landolt C) was -0.12 to -0.10, -0.05 and 0.10 logMAR (SV, DIMS, CL, MCL) at central gaze (0°). At nasal gaze (-22°), VA differed by 0.12, 0.33, 0.05 and 0.01, and at temporal gaze (+22°) by 0.05, 0.26, 0 and -0.08 compared with central gaze values. Mean CS (Contrast C) was 1.74, 1.73, 1.69 and 1.61 logCS (SV, DIMS, CL, MCL) at central gaze at nasal gaze, CS differed by -0.02 to -0.13, -0.01 and -0.01, and at temporal gaze by -0.02 to -0.16, -0.01 and +0.06 compared with central gaze values. Conclusion: When compared with SV, MCL leads to a general decrease in VA and CS, while DIMS did not differ from SV at straight gaze (0° gaze). With DIMS, VA and CS are decreased to a similar level as with the MCL, but only at nasal and temporal gaze.

[Optometric eye screening in schools : First results of a pilot project on logistical feasibility]. / Optometrische Schulreihenuntersuchungen : Erste Ergebnisse eines Pilotprojekts zur logistischen Machbarkeit.

BACKGROUND: We present a pilot project to improve eye health in schoolchildren: annual optometric screening with a focus on early detection of school myopia. The logistical proof-of-concept is illustrated by way of a pilot project at a state high school in North Rhine-Westphalia. The collected biometric parameters also contribute to the collection of epidemiological data. MATERIAL AND METHODS: On organized examination days objective and subjective refractions of schoolchildren in grades 5-7 (ages 9-16 years) were determined, children were tested for abnormalities in binocular vision and the photopic and mesopic pupil diameters were determined. Noncontact biometry was used to measure the corneal radius, central corneal thickness, anterior chamber depth, lens thickness and axial length of the eyes. Optical coherence tomography (OCT) was used to also determine the central choroidal thickness of the eyes. Questionnaires were employed to inquire about the visual habits of the schoolchildren. RESULTS: In the fall of 2019 a total of 274 schoolchildren (11.2 ± 1.2 years) voluntarily participated in the examinations: 22% (61) showed myopia (spherical equivalent ≤ -0.50 D), of which 11% (7) were previously uncorrected (uncorrected distance visual acuity < 0.8). Of the schoolchildren 8% (5) showed an increase in myopia of more than -0.5 D compared to their actual spectacle values (distance visual acuity with ophthalmic lens < 0.8). A class of about 25 pupils can be examined within 2 regular periods. CONCLUSION: There is an actual need for optometric screening because a total of 4.4% (12) myopic schoolchildren could be identified who had a distance visual acuity of less than 0.8 even with the correction. By determining the axial length and classifying this value depending on age in the literature can help to predict the individual risk of myopia and to raise awareness among parents and children to address this problem. The planned repetition of these examinations enables a better understanding of eye growth in schoolchildren.

[Optometric eye screening in schools : First epidemiological data for children and adolescents in grades 5-7]. / Optometrische Schulreihenuntersuchungen : Erste epidemiologische Daten von Kindern und Jugendlichen der 5. bis 7. Klasse.

BACKGROUND: Annually recurring optometric screening helps to identify children with increased axial growth and also to create awareness for wearing properly corrected glasses and for spending enough time outdoors, both of which are crucial for healthy eyes. The obtained biometric data help to expand the epidemiological information on myopia in schoolchildren, which is fundamental for the selection of the correct treatment. MATERIAL AND METHODS: Contact-free biometry of the eye was used to assess central corneal thickness, anterior chamber depth, lens thickness and axial length. Central choroidal thickness was manually assessed using optical coherence tomography (OCT). In addition, the mesopic and photopic pupil sizes were measured. RESULTS: Biometric data were obtained from 257 (mean age 11.2 ± 1.1 years, 31.9% female, n = 82, 68.1% male, n = 175) out of a total of 274 examined children. Mean corneal radius (mean ± SD, female/male) was 7.74 ± 0.23 mm/7.89 ± 0.22 mm, central corneal thickness was 556.80 ± 31.31 µm/565.68 ± 33.12 µm, anterior chamber depth was 3.62 ± 0.28 mm/3.71 ± 0.25 mm, lens thickness was 3.48 ± 0.18 mm/3.46 ± 0.17 mm and axial length was 23.03 ± 0.88 mm/23.51 ± 0.88 mm. Choroidal thickness was assessed in 240 children and was 335.12 ± 60.5 µm. Mesopic and photopic pupil sizes were 6.38 ± 0.70 mm and 3.11 ± 0.63 mm, respectively. CONCLUSION: The axial lengths found are consistent with the normal values for European children. A difference between male and female eyes could be observed. The repetition of these examinations in the future will enable the generation of growth charts.

Assessment of Reinjection Numbers and Intervals for Diabetic Macular Edema Patients Who Received Dexamethasone Intravitreal Implants in Germany and Switzerland.

PURPOSE: The purpose was to assess the number and intervals of dexamethasone intravitreal implant (DEX) reinjections in a real-world setting for the treatment of diabetic macular edema (DME) and to determine the relationship with effectiveness and safety. PATIENTS AND METHODS: Data were abstracted from medical records of DME patients in Germany and Switzerland for this retrospective, multicenter, drug utilization study. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) changes 7-12 weeks post-injection(s) measured effectiveness. Adverse events (AEs) of special interest were reported. RESULTS: A total of 141 patients, 108 from Germany and 33 from Switzerland, were assessed. Mean (SD) reinjection interval was 5.7 (4.2) months. Mean baseline BCVA was 61.6 letters, and mean baseline CRT was 413.3 µm. The mean BCVA and CRT changes at 7-12 weeks after baseline, reinjection 1, 2, and 3 were +3.4, +3.7, +3.2, and -1.4 letters and -88.3, -81.6, -102.4, and -124.1 µm, respectively. The Spearman correlation between change in BCVA and CRT and DEX reinjection interval was r=0.03 (P=0.66) and r=0.07 (P=0.38), respectively. Only 18% of patients experienced at least 1 AE. CONCLUSION: There was no statistically significant correlation between drug effectiveness and reinjection intervals in either country. Although these results are preliminary, they indicate that DEX improves BCVA and CRT in real-world clinical practice.

High-addition segmented refractive bifocal intraocular lens in inactive age-related macular degeneration: A multicenter pilot study.

This multicenter, open-label study aimed to determine the safety and functional outcome of a high-addition segmented refractive bifocal intraocular lens (IOL) in late inactive age-related macular degeneration (AMD). Twenty eyes of 20 patients were enrolled and followed until 12 months after the intervention. Patients underwent cataract surgery with implantation of a LS-313 MF80 segmented refractive bifocal intraocular lens with a near addition of +8.0 D (Teleon Surgical Vertriebs GmbH, Berlin, Germany). The main outcome measures were distance corrected near visual acuity (DCNVA) and safety as determined by intra- and post-operative complications. Secondary outcomes included distance corrected visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), the need for magnification to read newspaper, preferred reading distance, speed and performance (logRAD), as well as patient satisfaction. Mean DCNVA improved from 0.95 (±0.19) to 0.74 (±0.35) logMAR, until 6 months after surgery, P<0.05. CDVA improved from 0.70 (±0.23) to 0.59 (±0.30) logMAR, UDVA from 0.94 (±0.25) to 0.69 (±0.34) logMAR, UNVA from 1.08 (±0.19) to 0.87 (±0.43) logMAR. The mean need for magnification decreased from 2.9- to 2.3-fold, preferred reading distance from 23 to 20 cm. No intraoperative complications occurred during any of the surgeries. One patient lost > 2 lines of CDVA between 6 and 12 months, in another case, the study IOL was exchanged for a monofocal one due to dysphotopsia and decreased CDVA. Implantation of a segmented refractive bifocal IOL with +8.0 D addition improves near and distance vision in patients with late AMD and has a satisfactory safety profile.

Standalone Trabeculotomy and Viscodilation of Schlemm's Canal and Collector Channels in Open-Angle Glaucoma Using the OMNI Surgical System: 24-Month Outcomes.

PURPOSE: Intraocular pressure (IOP), medication outcomes at 24 months following trabeculotomy/viscodilation using the OMNI® surgical system as a standalone procedure in medically uncontrolled mild-moderate open-angle glaucoma (OAG). SETTING: Surgical center (Duesseldorf, Germany). DESIGN: Retrospective analysis. IOP and medication data were collected before surgery and through 24 months. Safety data included adverse events and the need for additional surgery. METHODS: Pre-op medication washout. Goldmann tonometry. Number of medications and adverse events (AE) at each time point. Primary outcomes: changes in IOP and medications. Two-sided paired t-tests compare values at each follow-up with baseline, significance p = 0.05. Secondary outcomes: proportion of eyes with IOP reduction of ≥20%, on fewer medications, and medication-free at each time point. RESULTS: This analysis included data from 38 eyes of 27 subjects. Mean (standard deviation) baseline IOP was 24.6 (3.0) mmHg and through 24 months ranged from 12.6 to 14.9 mmHg (p < 0.0001), representing reductions of 10.0-12.0 mmHg. Mean medications were 1.9 (baseline) and through 24 months ranged from 0.0 to 0.5 (70.6-100% reduction) (p < 0.0001). At Month 24, mean IOP was 14.9 mmHg (-10.0 mmHg), and 100% of eyes achieved IOP reduction >20% from baseline; mean medication use was 0.5 (-1.4 medications, p < 0.0001), 84.6% of eyes using >1 fewer medication, and 57.7% were medication-free. The most common adverse event was intraoperative hyphema (44.7%); all resolved spontaneously. There were two secondary procedures for IOP control. CONCLUSION: The OMNI surgical system provides clinically relevant and statistically significant reductions in both IOP and medications with an excellent safety profile and should be considered in phakic or pseudophakic eyes with mild-moderate OAG requiring IOP or medication reduction, or both.

[Myopia treatment and prophylaxis with defocus incorporated multiple segments spectacle lenses]. / Myopietherapie und Prophylaxe mit "Defocus Incorporated Multiple Segments"-Brillengläsern.

Excessive axial eye growth in children and adolescents leads to progressive myopia and can result in severe ocular diseases in adulthood. Various strategies have already been developed to inhibit progression of myopia. The novel single vision lens presented in this article features the defocus incorporated multiple segments (DIMS) technology and adds an easy to use, noninvasive option to the portfolio of myopia treatment. Initial studies showed promising results with only a very low side effect profile.