To determine the accuracy of two axis-marking methods for toric intraocular lens (IOL) implantation, one picture-assisted approach based on scleral vessel vectors, and the other based on a self-leveling device for manual marking. This retrospective single-center study involved 60 eyes of 51 participants, who underwent phacoemulsification with toric IOL implantation. In all eyes, preoperative markings were made in a seated position both manually via a self-leveling corneal marker (RoboMarker), and digitally on slit-lamp photographs, defining scleral vessels as landmarks, aiding to find the correct intraoperative orientation for an angular graduation instrument. The axis of IOL alignment at the end of surgery was determined from high resolution, intraoperative footage from a microscope-integrated camera and the axis-marking error served as an outcome measurement for both marking techniques. The endpoint was the alignment of the lens at the end of surgery. The average axis-marking error was 2.5 ± 1.9 degrees for picture-assisted marking, which was significantly less than that of the self-leveling corneal marker, being 5.4 ± 4.4 degrees. Our results indicate that scleral vessel vector marking leads to highly accurate toric IOL alignments, while being an inexpensive technique, as solely a slit-lamp camera is required for preoperative preparation.

BackgroundThe aim of this study was to compare the outcome of implantation of a XEN45 Gel Stent with the outcome of implantation of a Preserflo MicroShunt in a matched-pair analysis in eyes being na & iuml;ve to filtering surgery. MethodsIn this comparative, retrospective study, 50 eyes that had undergone XEN45 Gel Stent implantation were compared with 50 eyes after Preserflo implantation. Follow-up was at least 6 months, and surgical success was measured by criteria A (IOP < 21 mmHg, IOP reduction >20%, no repeat surgery); criteria B (IOP < 18 mmHg, IOP reduction >20%, no repeat surgery); and criteria C (IOP <= 15 mmHg, IOP reduction >= 40%, no repeat surgery). ResultsAfter a follow-up period of 12 months, mean IOP had decreased from preoperative 25.2 +/- 4.8 mmHg in the XEN group to 14.5 +/- 4.0 (n = 35) and from 25.3 +/- 6.8 mmHg to 11.9 +/- 2.9 (n = 41) in the Preserflo group, respectively. The IOP at the last follow-up of the two groups differed significantly (p < 0.01). The probability of surgical success did not differ concerning Criteria A and B, but surgical success was significantly higher in the Preserflo group for Criteria C (60%, p < 0.01). ConclusionBoth the Preserflo and XEN45 Gel Stent provide an effective and safe treatment option for advanced glaucoma and have a high potential to reduce intraocular pressure. Absolute IOP levels of <16 mmHg after 12 months were significantly more frequent in the Preserflo group.

PURPOSE:To determine differing outcomes among either phakic or pseudophakic patients who received standalone XEN45 Gel Stent (Allergan, an AbbVie Company, CA, USA) implantation and patients who underwent combined surgery with phacoemulsification. METHODS:This retrospective single-center study involved 180 eyes of 180 participants who underwent XEN45 Gel Stent implantation, of which 60 eyes received combined surgery with phacoemulsification (combined group). Standalone stent implantation was performed on 60 phakic (phakic group) and on 60 pseudophakic eyes (pseudophakic group). The groups were matched in a ratio of 1:1:1 based on multiple criteria. Successful surgery was defined by three scores: IOP at the longest follow-up of < 21 mmHg (Score A) or < 18 mmHg (Score B) and an IOP reduction > 20% or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). In all scores, one open conjunctival revision was allowed, and additional repeat surgery was considered a failure. RESULTS:After an average follow-up time interval of 20.6 ± 12.6 months, there was a mean IOP-reduction by 37% among the entire cohort. Comparative analysis between the three groups did not show significant differences regarding postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate or success rate. A dysfunctional stent was detected in eight eyes (4%) during open conjunctival revision in 76 eyes. CONCLUSION:The clinical endpoints investigated did not differ significantly among either phakic or pseudophakic patients who received standalone stent implantation and patients who underwent combined surgery. However mean latency between primary stent implantation and first revision surgery after combined surgery was markedly shorter.

To investigate in combined iStent inject implantation with phacoemulsification carried out bilaterally, whether intraocular pressure (IOP)‐lowering effectiveness in the first eye has a predictive potential for the outcome of the second eye in primary open‐angle glaucoma (POAG).

To determine the predictability of success and the risk of open conjunctival revision in the subsequent eye after XEN45 Gel Stent implantation according to lens status. This was a retrospective single-centre study involving 132 eyes of 66 participants who had undergone intraocular pressure (IOP)-lowering XEN45 Gel Stent implantation, either as a standalone procedure in phakic and pseudophakic eyes or in combination with phacoemulsification. Successful surgery was defined by three scores: IOP at follow-up < 21 mmHg (score A) or < 18 mmHg (score B) and an IOP reduction > 20% or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (score C). In all scores, one open conjunctival revision was allowed, and additional repeat surgery was considered a failure. The predictability of success and revision rate depending on the outcome of the first eye were calculated using Bayes’ theorem. IOP-lowering did not differ significantly between the first and second eyes. Success rates of standalone surgery in the second eye after successful surgery in the first eye significantly exceed rates after prior failure. For the combined procedure, the rates did not differ significantly. For score A, we determined a 76.6% chance of success following a prior success and a 57.9% chance, if prior surgery failed. The corresponding probabilities were 75% and 59.1% for score B, while 66.7% and 15.7% for score C, respectively. We calculated a 60% risk for revision surgery in the standalone phakic group. If the first eye was not revised, the risk of revision in the subsequent eye was 20%. The corresponding risks were 72.7% and 5% for the standalone procedure in pseudophakic patients and 38.4% and 41.7% for the combined procedure, respectively. The results of our study offer a tool to predict the outcome of subsequent eye surgeries based on either the outcome in the initial eye and the type of surgery performed, owing to the high predictive potential.

Introduction: Visual prostheses, i.e. epiretinal stimulating arrays, are a promising therapy in treating retinal dystrophies and degenerations. In the wake of a new generation of devices, an innovative method for epiretinal fixation of stimulator arrays is required. We present the development of tailor-made bioadhesive peptides (peptesives) for fixating epiretinal stimulating arrays omitting the use of traumatic retinal tacks. Materials and methods: Binding motifs on the stimulating array (poly[chloro-p-xylylene] (Parylene C)) and in the extracellular matrix of the retinal surface (collagens I and IV, laminin, fibronectin) were identified. The anchor peptides cecropin A (CecA), KH1, KH2 (author's initials) and osteopontin (OPN) were genetically fused to reporter proteins to assess their binding behavior to coated microtiter plates via fluorescence-based assays. Domain Z (DZ) of staphylococcal protein A was used as a separator to generate a bioadhesive peptide. Following ISO 10993 "biological evaluation of medical materials", direct and non-direct cytotoxicity testing (L-929 and R28 retinal progenitor cells) was performed. Lastly, the fixating capabilities of the peptesives were tested in proof-of-principle experiments. Results: The generation of the bioadhesive peptide required evaluation of the N- and C-anchoring of investigated APs. The YmPh-CecA construct showed the highest activity on Parylene C in comparison with the wildtype phytase without the anchor peptide. eGFP-OPN was binding to all four investigated ECM proteins (collagen I, laminin > collagen IV, fibronectin). The strongest binding to collagen I was observed for eGFP-KH1, while the strongest binding to fibronectin was observed for eGFP-KH2. The selectivity of binding was checked by incubating eGFP-CecA and eGFP-OPN on ECM proteins and on Parylene C, respectively. Direct and non-direct cytotoxicity testing of the peptide cecropin-A-DZ-OPN using L-929 and R28 cells showed good biocompatibility properties. Proof-of-concept experiments in post-mortem rabbit eyes suggested an increased adhesion of CecA-DZ-OPN-coated stimulating arrays. Conclusion: This is the first study to prove the applicability and biocompatibility of peptesives for the fixation of macroscopic objects.

Background/Purpose: To determine anatomical success and best-corrected visual acuity after secondary surgery with heavy silicone oil tamponade in patients with persistent full-thickness macular holes. Methods: In this retrospective study, 63 eyes with persistent full-thickness macular holes after primary pars plana vitrectomy and internal limiting membrane peeling underwent secondary surgery with heavy silicone oil tamponade. Macular spectral domain optical coherence tomography and best-corrected visual acuity measurements were performed during the follow-up. Results: Fifty of 63 eyes (79.4%) achieved anatomical success. In eyes achieving anatomical success, best-corrected visual acuity before primary vitreoretinal surgery was significantly better (0.77 [∼20/125 Snellen] ± 0.24 [1.3–0.3] logarithm of the minimum angle of resolution) compared with eyes not achieving anatomical success (0.88 [∼20/160 Snellen] ± 0.17 [1.1–0.6] logarithm of the minimum angle of resolution, P = 0.044). Minimum linear diameter of full-thickness macular holes was significantly smaller in eyes achieving anatomical success, both before primary (403.4 ± 128.7 [199.0–707.0] µm vs. 568.1 ± 209.1 [307.0–953.0] µm, P = 0.009) and secondary surgery (464.1 ± 215.0 [178.0–1,521.0] µm vs. 663.3 ± 228.5 [451.0–1,301.0] µm, P = 0.010). Patients remaining phakic during all three surgeries did not benefit from best-corrected visual acuity improvement, although anatomical success was achieved. Conclusion: Heavy silicone oil tamponade in secondary surgery for persistent full-thickness macular holes is a safe and efficient surgical method. Best-corrected visual acuity and minimum linear diameter before surgery may be indicators for anatomical success.

Background To determine whether the outcome of the first eye may serve as a predictor for intraocular pressure (IOP)-lowering effectiveness in the second eye following bilateral ab interno trabeculectomy. Methods This retrospective single-centre study included 168 eyes from 84 participants, who underwent combined Trabectome surgery with phacoemulsification cataract surgery in a hospital setting. The clinical endpoint was defined as either 'success' or 'failure' based on four separate scores at the longest follow-up time point: IOP at follow-up <21 mm Hg (Score A) or IOP < 18 mm Hg (Score B), without re-surgery and IOP reduction >20%; IOP <= 15 mm Hg without re-surgery and IOP reduction >= 40% (Score C); and the sole absence of re-surgery according to the discretion of the surgeon (Score D). Results No significant difference was observed between the outcomes of first and second eyes. The frequency of success in the second eye after effective surgery in the first eye significantly exceeded that after prior failure. Within our analysis, the probability calculations determined a 75% chance of success following prior success for Score A. If surgery in the first eye failed, the chance of success in the subsequent eye was 37%. The corresponding probabilities were 79% and 32% for Score B, 56% and 9% for Score C, and 99% and 50% for Score D. Conclusion The results of our study offer a useful tool to assess the success of subsequent eye surgeries based on the outcome in the initial eye, owing to the high predictive potential.

INTRODUCTION:We report a case of endophthalmitis and endocarditis that developed after stent perforation following a XEN45 Gel Stent implantation 10 months ago.CASE REPORT:A 79-year-old man was referred to our hospital because of endophthalmitis of the right eye. The patient had undergone XEN45 Gel Stent implantation in the same eye 10 months ago. On examination, the conjunctiva was perforated by the stent, and it was no longer covered by the conjunctiva. A 27-G pars plana vitrectomy with intravitreal antibiotic injection was performed. Moreover, the patient received intravenous antibiotic treatment and local anti-inflammatory and anti-infectious therapy. Streptococcus gordonii was identified as a bacterial cause of the endophthalmitis. Therefore, transesophageal echocardiography was performed, which revealed aortic valve endocarditis.DISCUSSION:Although not proven, it is possible that the exposed XEN45 Gel Stent served as an entry point for S. gordonii, which caused the exogenous endophthalmitis and subsequent endocarditis. S. gordonii belongs to the viridans group streptococci, which is the etiological agent for endocarditis which is a severe and potentially life-threatening infection. Ophthalmologists should therefore consider the risk of systemic infections as endocarditis after endophthalmitis, particularly caused by the viridans group streptococci, which are known etiological agents of endocarditis.

Purpose: This study investigates the long-term intraocular pressure (IOP) lowering potential, risk profile and success rate of a triple procedure comprising phacoemulsification, trabecular aspiration and trabectome (Microsurgical Technology, Redmond, WA, USA) for treating exfoliation glaucoma. Methods: A total of 117 eyes of 117 patients with exfoliation glaucoma underwent a combination of phacoemulsification, trabectome and trabecular aspiration. They were followed up for up to 7 years. The success rates were designated according to criteria based on the Tube versus Trabeculectomy Study and the World Glaucoma Association guidelines: A (no resurgery); B/C (IOP < 21/18 mmHg, no resurgery, IOP reduction > 20%); D (IOP ⩽ 15 mmHg, no resurgery, IOP reduction ⩾ 40%). Results: The mean follow-up period was 46 months. IOP showed a 38% reduction from 24.5 ± 6.1 to 15.2 ± 3.6 mmHg ( p < 0.0001). The Medication Score decreased by 23% from 2.2 ± 0.9 to 1.7 ±1.0 ( p < 0.0001). The success rates were 87, 76, 74 and 38% according to criteria A, B, C and D. In eyes with an initial IOP of >30 mmHg, a 57% reduction from 34.2 ± 4.4 to 14.8 ± 3.2 mmHg ( p < 0.0001) was observed, and the success rates were 91, 91, 82 and 59% for criteria A, B, C and D, respectively. Discussion: We conclude that the triple procedure may effectively lower IOP in patients with exfoliation glaucoma over a mean follow-up period of 46 months without significant side effects. Therefore, the triple procedure may serve as first-line surgery for patients with exfoliation and cataract, even with a high initial IOP.

Purpose We assessed the accuracy of lens power calculation in highly myopic patients implanting plus and minus intraocular lenses (IOL). Methods We included 58 consecutive, myopic eyes with an axial length (AL) > 26.0 mm, undergoing phacoemulsification and IOL implantation following biometry using the IOLMaster 500. For lens power calculation, the Haigis formula was used in all cases. For comparison, refraction was back-calculated using the Barrett Universal II (Barrett), Holladay I, Hill-RBF (RBF) and SRK/T formulae. Results The mean axial length was 30.17 ± 2.67 mm. Barrett (80%), Haigis (87%) and RBF (82%) showed comparable numbers of IOLs within 1 diopter (D) of target refraction. Visual acuity (BSCVA) improved ( p < 0.001) from 0.60 ± 0.35 to 0.29 ± 0.29 logMAR (> 28-days postsurgery). The median absolute error (MedAE) of Barrett 0.49 D, Haigis 0.38, RBF 0.44 and SRK/T 0.44 did not differ. The MedAE of Haigis was significantly smaller than Holladay (0.75 D; p = 0.01). All median postoperative refractive errors (MedRE) differed significantly with the exception of Haigis to SRK/T ( p = 0.6): Barrett − 0.33 D, Haigis 0.25, Holladay 0.63, RBF 0.04 and SRK/T 0.13. Barrett, Haigis, Holladay and RBF showed a tendency for higher MedAEs in their minus compared to plus IOLs, which only reached significance for SRK/T ( p = 0.001). Barrett ( p < 0.001) and RBF ( p = 0.04) showed myopic, SRK/T ( p = 002) a hyperopic shift in their minus IOLs. Conclusions In highly myopic patients, the accuracies of Barrett, Haigis and RBF were comparable with a tendency for higher MedAEs in minus IOLs. Barrett and RBF showed myopic, SRK/T a hyperopic shift in their minus IOLs.

Background After implantation of a XEN gel stent scarring of the conjunctiva with elevation of the intraocular pressure (IOP) is a frequent occurrence. This article describes a surgical revision technique with opening of the conjunctiva and removal of scar tissue. In order to standardize the technique the surgical procedure was divided into nine steps. These steps are shown in the video and a series of images. Methods Surgery is divided into nine steps: 1) corneal traction suture and topical application of suprarenin, 2) opening of the conjunctiva along the limbus, 3) preparation posteriorly towards the fornix, 4) separation of the stent from the surrounding scar tissue, 5) precise preparation of the stent, 6) removal of additional scar tissue not adhering to the stent, 7) functional testing of the stent, 8) mitomycin C application, 9) closing of the conjunctiva with two corner sutures on the limbus. Results After surgery a diffuse filtering bleb is formed. In the literature increased success rates up to 90% (criterion: no further surgery necessary) after open conjunctival revision have been described. Severe side effects are not to be expected and are comparable to those of primary surgery. Conclusion Open revision of the conjunctiva after XEN gel stent implantation leads to an effective and enduring lowering of IOP. Revision surgery can be carried out even after a long time period and can keep the patient free of antiglaucomatous drops. Experience in surgery of filtering blebs is advantageous when performing open revision of the conjunctiva.

Precis: The XEN45 Gel Stent can be implanted after failed trabeculectomy without disadvantages compared with primary implantation. Purpose: We aimed to compare the outcomes of XEN45 Gel Stent implantation in pseudophakic eyes after failed trabeculectomy and in pseudophakic eyes without other previous surgeries. Patients and Methods: In this retrospective study, we included 30 pseudophakic eyes of 30 patients who underwent XEN45 Gel Stent implantation after failed trabeculectomy (trabeculectomy group) and 60 eyes of 60 patients with primary XEN45 Gel Stent implantation (control group). The groups were matched for preoperative intraocular pressure (IOP), preoperative medication score, cup-to-disc ratio, follow-up time, visual acuity, and age at a ratio of 1:2. Eyes with concomitant eye diseases, those who had undergone previous surgery, and those with a follow-up duration <6 months were excluded. We compared the success rates on the basis of different criteria: Criteria A (IOP<21 mm Hg, IOP reduction>20%, no repeat surgery); Criteria B (IOP<18 mm Hg, IOP reduction>20%, no repeat surgery); and Criteria C (IOP≤15 mm Hg, IOP reduction≥40%, no repeat surgery). Results: After an average follow-up period of 20 months, the mean IOP was reduced from 24.4±5.7 to 14.0±4.1 mm Hg in all the study subjects (90 patients). There were no significant differences between the 2 groups in postoperative IOP, postoperative medication score, revision rate, and repeat surgery rate or success rate. Conclusions: XEN45 Gel Stent implantation is a viable option after failed trabeculectomy. According to our results, it has no disadvantage compared with primary XEN45 Gel Stent implantation.

Objective . The restoration of vision in blind patients suffering from degenerative retinal diseases like retinitis pigmentosa may be obtained by local electrical stimulation with retinal implants. In this study, a very large electrode array for retinal stimulation (VLARS) was introduced and tested regarding its safety in implantation and biocompatibility. Further, the array’s stimulation capabilities were tested in an acute setting. Approach . The polyimide-based implants have a diameter of 12 mm, cover approximately 110 mm 2 of the retinal surface and carrying 250 iridium oxide coated gold electrodes. The implantation surgery was established in cadaveric porcine eyes. To analyze biocompatibility, ten rabbits were implanted with the VLARS device, and observed for 12 weeks using slit lamp examination, fundus photography, optical coherence tomography (OCT) as well as ultrasound imaging. After enucleation, histological examinations were performed. In acute stimulation experiments, electrodes recorded cortical field potentials upon retinal stimulation in the visual cortex in rabbits. Main results . Implantation studies in rabbits showed that the implantation surgery is safe but difficult. Retinal detachment induced by retinal tears was observed in five animals in varying severity. In five cases, corneal edema reduced the quality of the follow-up examinations. Findings in OCT-imaging and funduscopy suggested that peripheral fixation was insufficient in various animals. Results of the acute stimulation demonstrated the array’s ability to elicit cortical responses. Significance . Overall, it was possible to implant very large epiretinal arrays. On retinal stimulation with the VLARS responses in the visual cortex were recorded. The VLARS device offers the opportunity to restore a much larger field of visual perception when compared to current available retinal implants.

Introduction: We report a case of XEN45 Gel Stent removal 3 years after its implantation. The stent had degraded with a closed lumen, so a new stent was implanted. Case Report: A 63-year-old woman was scheduled for XEN45 Gel Stent implantation. Three years after the primary surgery and 2 years after a surgical revision, second revision surgery was required. The conjunctiva was opened, and the implanted XEN Gel Stent was stripped of the adhesive scar tissues. No aqueous humor flow was seen through the stent, and therefore, the stent was removed. The intrascleral and intracameral parts had degraded. The surface of the stent was irregular and cobbled. A part of the lumen in the middle of the stent had closed. Discussion: We detected changes in the stent after its removal during the surgical revision with conjunctival opening, which is our standard approach for failed XEN Gel Stents. Most surgeons advise needling of the stent in cases of failure. However, in cases of needling, changes in the stent might not have been detected. Thus, the number of patients with similar changes as this report might be higher than the publications suggest. No unique characteristics distinguished this patient from those who had a functional XEN Gel Stent. The stent, in this case, might have been of inferior quality as an exception, or all stents might degrade over time. Therefore, gonioscopy should be performed carefully to detect any changes in the stent. In cases of suspected stent degradation, we recommend a revision surgery with conjunctival opening and removal of the stent in cases of degradation.

Trabectome surgery combined with phacoemulsification is effective in lowering (intraocular pressure) IOP in pseudoexfoliation glaucoma. Trabectome surgery usually aims to remove two to four clock hours of the trabecular meshwork. When adding trabecular aspiration, the remaining meshwork can be treated as well, and therefore 360 degrees of the meshwork can be reached. This study was conducted to investigate the additional benefits and risks of adding trabecular aspiration to the combination of phacoemulsification and trabectome as a triple procedure.

Purpose: To determine ocular side effects of vardenafil with special regard to color vision and retinal function. Methods: This was a single center, randomized, double-blind, placebo-controlled, twofold crossover study with an administration of a single oral dose of two 20 mg tablets of RAY 38-9456 ( vardenafil hydrochloride) or corresponding placebo in 24 healthy male subjects. Ocular investigations included Farnsworth Munsell D100 color vision test, electroretinogram, and basic ophthalmological examinations like visual acuity, visual field, and slit-lamp of anterior segment and fundus. Results: Compared to placebo, administration of vardenafil hydrochloride lead to a temporary significant increase of Farnsworth-Munsell D100 total error score after 1 and 6 hours as well as in error lines 3 and 4 after 1 hour. Twenty-four hours after administration there was no significant alteration of total error score or of any error line. While latency of electroretinogram b-wave remained unaffected, amplitudes showed a significant decrease compared to placebo 1 hour following administration. While other ocular examinations did not reveal any differences in general some mild to moderate but no serious adverse events have been reported. Conclusion: Despite temporary changes in retinal function our study reports good tolerability of vardenafil in regard to ocular side effects.

Background It is unclear whether or not an additional encircling band improves outcome in vitrectomy for pseudophakic retinal detachment (PRD). Also unclear is whether small gauge transconjunctival trocar-guided vitrectomy is as successful as conventional 20 gauge (G) vitrectomy.Methods 257 adult patients with uncomplicated PRD were enrolled in 14 vitreoretinal centres across Germany. Contingent on availability of qualified surgeons, eligible patients were randomly assigned either (i) with ratio 1: 1 to 20 G vitrectomy plus encircling band (group E1) or 20 G vitrectomy without any buckle (group C) or (ii) with ratios 1: 1: 1 to group E1, C or 23/25 G vitrectomy without any buckle (group E2). Treatment success was defined as no indication for any retina reattaching procedure during the follow-up of 6 months.Results Success was reached in 79.0% (=79/100, group E1) versus 73.5% (=72/98, group C) (p=0.558, OR 1.32, 95% CI 0.65 to 2.65. In group E2 87.7% (=50/57) of patients reached success compared with 78.7% (=48/61) in group C, demonstrating noninferiority of E2 to C regarding the prespecified margin of 0.8 (OR scale; p=0.05, OR 2.17, 95% CI 0.80 to 5.89). Best corrected visual acuity significantly increased after surgery independent of technique, that is, on average -0.7 (from 1.0 to 0.3) logMAR. Patients suffered from a shift in spherical refraction of -1.0 D in group E1 compared with -0.1 D in group C. Similarly, intraoperative complications (15.2% vs 8.8% of patients) and serious adverse events (30.3% vs 22.5% of patients) were more frequent in group E1.Conclusions Vitrectomy with gas is an efficient and safe treatment for uncomplicated PRD. An additional encircling band does not significantly reduce the risk for any second procedure necessary to reattach the retina in 20 G vitrectomy. Small gauge transconjunctival vitrectomy is not inferior to the conventional 20 G technique.