7-Year Efficacy and Safety of iStent inject Trabecular Micro-Bypass in Combined and Standalone Usage.

INTRODUCTION: This study evaluated 7-year effectiveness and safety of second-generation trabecular micro-bypass implantation (iStent inject) either in combination with cataract surgery or as a standalone procedure (Combined or Standalone subgroups, respectively) in eyes with open-angle glaucoma. METHODS: This prospective, non-randomized, unmasked, longitudinal study included 125 consecutive iStent inject cases of a single surgeon at a large German academic hospital. Patients had considerable preoperative disease burden, with mean intraocular pressure (IOP) of 23.5 mmHg, 84.8% of eyes on ≥ 2 medications, and 38.4% of eyes with prior glaucoma surgery. IOP, medications, adverse events, and secondary surgeries were assessed through 7 years in the Overall cohort and in Combined (n = 81) and Standalone (n = 44) subgroups. RESULTS: Over 7-year follow-up, mean IOP decreased by 36.2-40.0% in Overall eyes, 34.1-38.9% in Combined eyes, and 39.5-43.5% in Standalone eyes (p < 0.001 at all timepoints for all groups). Meanwhile, mean medications decreased by 59.3-71.3% in Overall eyes, 57.9-69.0% in Combined eyes, and 62.1-76.2% in Standalone eyes (p < 0.001 at all timepoints in all groups). At last follow-up (mean 77.4 months; 92.8% of patients with last visit at 6 or 7 years), 83.7% of Overall eyes, 82.3% of Combined eyes, and 86.4% of Standalone eyes had achieved ≥ 20% IOP reduction vs preoperative. At last follow-up vs preoperative, 100% of eyes in all groups had the same or lower IOP and 100% had the same or lower medication regimen. Safety outcomes were favorable, with no filtration surgeries and only 4.84% of eyes experiencing clinically significant visual field loss over 7 years of follow-up. CONCLUSION: iStent inject implantation with or without phacoemulsification produced significant and durable 7-year reductions in IOP (~ 34-44% reduction) and medications (~ 58-76% reduction) while preventing filtering surgery in this cohort of patients with relatively high preoperative disease burden. Combined and Standalone cases had similarly favorable effectiveness and safety.

iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control.

INTRODUCTION: This study evaluated the 5-year effectiveness and safety of iStent inject® trabecular micro-bypass with or without cataract surgery (Combined or Standalone, respectively) in patients with open-angle glaucoma (OAG). METHODS: This prospective longitudinal case series included consecutive iStent inject cases from a single surgeon at a large German academic hospital. Intraocular pressure (IOP), medications, safety, and indicators of disease stability through 5 years were assessed in the Overall cohort and in subgroup analyses stratified by usage (Combined or Standalone). RESULTS: Preoperative mean IOP in the Overall cohort (n = 125) was 23.5 ± 6.2 mmHg on 2.68 ± 1.02 mean medications, reducing to 14.1 ± 1.8 mmHg on 0.77 ± 0.82 medications at 5 years (40% and 71% reductions, respectively; both p < 0.001). All but 1 eye (> 99%) were on medication(s) preoperatively, but 46% were medication-free at 5 years (p < 0.001). In Combined eyes (n = 81), mean IOP decreased by 39% (22.6 mmHg to 13.8 mmHg, p < 0.001) and medications by 69% (2.52 to 0.78, p < 0.001). In Standalone eyes, mean IOP reduced by 42% (25.3 mmHg to 14.6 mmHg, p < 0.001) and medications by 75% (2.98 to 0.74, p < 0.001). At final follow-up, 83% of eyes had achieved ≥ 20% IOP reduction, and all but 1 eye (> 99%) had the same or lower IOP versus preoperative; all eyes (100%) maintained or reduced their medication burden versus preoperative. Favorable safety included 0 intraoperative complications and 0 filtration surgeries through 5 years. Long-term indicators of disease stability (visual fields, retinal nerve-fiber layer thickness, and cup:disc ratio) were unchanged over the course of 5-year follow-up. CONCLUSIONS: iStent inject produced significant and durable 5-year reductions in IOP (nearly 10-mmHg reduction) and medications (nearly 2-medication reduction), with stable disease parameters over time. Combined and Standalone subgroups had similar outcomes.

Long-term follow-up and clinical evaluation of the light-adjustable intraocular lens implanted after cataract removal: 7-year results.

PURPOSE: To determine the long-term safety and effectiveness of a light-adjustable intraocular lens (LAL) over a period that is longer than reported in the literature at the time of the study. SETTING: University Eye Hospital, Bochum, Germany. DESIGN: Noninterventional observation. METHODS: In 445 patients, cataract surgery with LAL implantation was performed between April 2008 and December 2012. It was possible to contact 171 of these patients or their relatives through letter or telephone; 61 patients (103 eyes) agreed to participate in the long-term study and were examined. RESULTS: The mean time between the lock-in (final light treatment) and long-term visit was 7.2 years; 61 patients were included and examined. Corrected and uncorrected distance visual acuity was and remained good (n = 93). The refractive outcome was stable with minimal deviation. There were no significant changes in corneal thickness. In 2 patients, there were slight opacities of the IOL material without impact on visual acuity. Other eye diseases were within the normal range of the patients' age. CONCLUSION: Seven years after implantation and refractive adjustment, eyes with an LAL had stable refraction, good visual acuity, and no IOL-associated pathologies. The findings suggest that LAL technology is a safe and efficient method to achieve good visual results without long-term complications.

Comparison of Minimally Invasive XEN45 Gel Stent Implantation in Glaucoma Patients Without and With Prior Interventional Therapies.

INTRODUCTION: The aim of our analysis was to compare the effectiveness of the XEN45 gel stent implantation in patients without and with prior glaucoma intervention. METHODS: Retrospective analysis including 148 medical records of consecutive glaucoma eyes without prior glaucoma intervention (group A, n = 45) or with prior glaucoma intervention (group B, n = 103). Follow-up data up to 12 months after XEN45 gel implantation were available for all eyes. RESULTS: At 12 months, qualified success (IOP reduction of ≥ 20% and IOP < 18 mmHg without and with medication) was achieved in 76% of eyes in group A and in 72% of eyes in group B; corresponding values for complete success (IOP reduction of ≥ 20% and IOP < 18 mmHg without medication) were 56% and 55%. Mean IOP was significantly reduced by 58% from 36.0 ± 10.7 mmHg preoperatively to 14.2 ± 3.4 mmHg at 12 months in group A (p = 0.000) and by 53% from 31.6 ± 8.9 mmHg to 14.3 ± 4.2 mmHg and in group B (p = 0.000). The mean number of hypotensive medications had significantly decreased from 3.6 ± 0.8 at baseline to 0.3 ± 0.7 medications in group A (p = 0.000) and from 3.0 ± 1.0 to 0.3 ± 0.7 medications in group B (p = 0.000). Needling was required in 29% of eyes in group A and in 35% of group B within 12 months. No statistically significant differences were observed between eyes without and with prior glaucoma intervention. CONCLUSION: The 1-year results of our retrospective analysis indicate that patients without and with previous glaucoma intervention can benefit from XEN45 gel stent implantation. Both groups achieved significant and similar reductions in IOP and hypotensive medication, with a slight trend towards greater reductions in eyes without prior glaucoma intervention. Further controlled prospective studies with longer follow-ups are required. FUNDING: Editorial support and article processing charges were funded by Allergan.

Second-Generation Trabecular Micro-Bypass Stents as Standalone Treatment for Glaucoma: A 36-Month Prospective Study.

INTRODUCTION: To evaluate long-term outcomes following stand-alone implantation of two second-generation trabecular micro-bypass stents (iStent inject®, Glaukos Corp., San Clemente, CA, USA) in eyes with predominantly primary open-angle glaucoma (POAG) and considerable preoperative disease burden. METHODS: Eyes with POAG, pseudoexfoliative glaucoma (PXG), appositional narrow-angle glaucoma (NAG, with open-angle configuration in the area of implantation), or secondary glaucoma were included in this prospective, non-randomized, consecutive case series. All eyes underwent ab interno iStent inject implantation as a sole procedure. Assessments through 36 months included IOP, medications, corrected distance visual acuity (CDVA), secondary glaucoma surgeries, and complications and adverse events. RESULTS: Two iStent inject stents were implanted in 44 consecutive eyes (POAG = 38, PXG = 4, appositional NAG = 1, secondary neovascular glaucoma = 1) of 31 patients, and 33 eyes had 36-month follow-up data. Preoperative mean IOP was 25.3 ± 6.0 mmHg on a mean of 2.98 ± 0.88 medications, with 75% of eyes on 3-5 medications, no eyes medication-free, and 50% of eyes with history of prior glaucoma surgery. At 36 months postoperatively, mean IOP reduced by 42% to 14.6 ± 2.0 mmHg (p < 0.0001) and 87.9% of eyes achieved an IOP reduction of ≥ 20% versus preoperatively. In addition, 97% of eyes reached IOP ≤ 18 mmHg (vs. 9.1% preoperatively; p < 0.0001) and 70.0% of eyes reached IOP ≤ 15 mmHg (vs. 2.3% preoperatively; p < 0.0001). Mean medication burden decreased by 82% to 0.55 ± 0.79 (p < 0.0001), and 61% of eyes became medication-free. All eyes maintained or decreased their 36-month medication burden versus preoperatively. Safety was favorable, including minimal adverse events and stable CDVA through 36 months postoperatively. CONCLUSION: This real-world cohort of glaucomatous eyes with substantial preoperative disease burden experienced significant, sustained, safe IOP and medication reductions through 36 months following stand-alone iStent inject implantation. FUNDING: Article processing charges and writing assistance were provided by Glaukos Corp. (San Clemente, CA, USA).

Ab interno gel implant in patients with primary open angle glaucoma and pseudoexfoliation glaucoma.

PURPOSE: To compare efficacy and safety results of an ab interno gel implant in patients with pseudoexfoliation glaucoma (PXG) and primary open angle glaucoma (POAG). METHODS: Retrospective analysis of the medical records of 110 consecutive eyes with open angle glaucoma who had received a XEN45 gel implant between March 2014 and June 2015. Intraocular pressure course, number of glaucoma medications, the need for additional intervention (including needling) and complications were evaluated until 12 months postoperatively. RESULTS: Data of 67 eyes with POAG and 43 eyes with PXG were analyzed. At 12 months postoperatively, the mean IOP had significantly decreased by 54.0% from preoperatively 31.85 ± 8.5 mmHg to 13.99 ± 2.6 mmHg in the POAG group, (p = 0.000; Wilcoxon test), and by 55.2% from 31.63 ± 9.0 mmHg to 13.28 ± 3.1 mmHg in the PXG group (p = 0.000; Wilcoxon test). The mean number of anti-glaucoma medications had significantly decreased from 3.25 ± 0.8 at baseline to 0.3 ± 0.7 medications at 12 months postoperatively in POAG eyes (p = 0.000; Wilcoxon test), and from 3.05 ± 1.0 to 0.3 ± 0.6 medications in PXG eyes (p = 0.000; Wilcoxon test). Hypotony (IOP ≤ 6 mmHg) was observed in 2 POAG eyes (3.0%) and in 5 PXG eyes (11.7%) at 1 month but normalized in all eyes at 12 months postoperatively. Severe complications were not observed. No statistically significant differences were found between PXG eyes and POAG eyes. CONCLUSION: Our data indicate that the XEN45 gel implant provides significant and comparable reduction in IOP and anti-glaucoma medication during the one-year follow-up period in POAG as well as PXG eyes. This suggests that it may be a noteworthy alternative to traditional filtering procedures in patients with POAG and PXG respectively.

Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass Stents with Phacoemulsification in Eyes with Various Types of Glaucoma.

INTRODUCTION: The aim of this study was to assess 36-month outcomes after cataract surgery and implantation of two second-generation trabecular micro-bypass stents (iStent inject, Glaukos Corporation, San Clemente, CA, USA) into eyes with predominantly primary open-angle glaucoma (POAG) or pseudoexfoliative glaucoma (PEX). METHODS: This prospective, non-randomized, consecutive cohort study included eyes with POAG (n = 60), PEX (n = 15), appositional narrow-angle (n = 4), pigmentary (n = 1), or neovascular (secondary) (n = 1) glaucoma and cataract requiring surgery. All eyes (n = 81) underwent ab interno iStent inject implantation following cataract surgery. Effectiveness endpoints through 36 months included intraocular pressure (IOP), number of medications, and proportion of eyes with ≥ 20% IOP reduction, IOP ≤ 18 mmHg, and IOP ≤ 15 mmHg. Safety measures included corrected distance visual acuity (CDVA), adverse events, and secondary surgeries. Outcomes were evaluated for the overall cohort, and for the POAG and PEX subgroups. RESULTS: Preoperatively, 32.1% of eyes had undergone prior glaucoma surgery, 56% were on 3-4 medications, and 1 eye (1%) was medication-free. At 36 months postoperatively, mean IOP reduced by 37% (14.3 ± 1.7 mmHg versus 22.6 ± 6.2 mmHg preoperatively), and mean medication burden decreased by 68% (0.8 ± 0.9 versus 2.5 ± 1.1 medications preoperatively). IOP reduced by ≥ 20% in 78% of eyes; 100% of eyes reached IOP ≤ 18 mmHg and 71% reached ≤ 15 mmHg. Medication burden reduced considerably: 22 eyes (54%) were medication-free compared to 1 eye (1%) preoperatively; 1 eye (2%) required ≥ 3 medications compared to 45 eyes (56%) preoperatively; and 92.7% of eyes required reduced medications postoperatively. From 3 through 36 months, mean IOP remained ≤ 15.0 mmHg, and mean number of medications remained ≤ 0.9. Outcomes in the POAG and PEX subgroups included 33% and 32% lower IOP, and 68% and 64% fewer medications, respectively. iStent inject showed a favorable safety profile, including no intraoperative complications, minimal adverse events, and a stable CDVA. CONCLUSION: This real-world cohort of eyes with various types of glaucoma and considerable disease burden exhibited durable and safe IOP and medication reductions through 36 months following iStent inject implantation with cataract surgery. Outcomes were similarly beneficial in eyes with POAG and PEX. FUNDING: Article processing charges were funded by Glaukos Corporation (San Clemente, CA, USA).

Standalone Ab Interno Gelatin Stent versus Trabeculectomy: Postoperative Interventions, Visual Outcomes, and Visits.

PURPOSE: To evaluate postoperative interventions, visual outcomes, and number of postoperative office visits after standalone ab interno gelatin microstent implantation with mitomycin C (MMC) vs. trabeculectomy with MMC. DESIGN: International, multicenter, retrospective cohort study. PARTICIPANTS: A total of 354 eyes of 293 patients, including 185 microstent eyes and 169 trabeculectomy eyes. METHODS: Consecutive eyes with uncontrolled glaucoma underwent microstent or trabeculectomy surgery from January 1, 2011, through July 31, 2015, at 4 academic ophthalmology centers: Toronto, Canada; Frankfurt, Germany; Salzburg, Austria; and Leuven, Belgium. MAIN OUTCOME MEASURES: Assessed outcomes included (1) in-clinic interventions, (2) transconjunctival needle revision (TCNR), (3) postoperative visits at 1 and 3 months, (4) >2 lines vision loss at last follow-up, (5) complete visual recovery, and (6) >0.5 or >1 diopter (D) of surgically induced astigmatism. RESULTS: Ninety-five (51.4%) of the microstent eyes and 105 (62.1%) of the trabeculectomy eyes underwent an intervention by last follow-up (log-rank P = 0.0004). The most common intervention was TCNR, followed by laser suture lysis. Seventy-eight (42.2%) microstent eyes and 55 (32.5%) trabeculectomy eyes received TCNR (adjusted hazard ratio [HR], 1.73 [95% confidence interval (CI), 1.10-2.71]): 128 total TCNRs in the microstent group and 95 in the trabeculectomy group. Predictors for TCNR included prior laser peripheral iridotomy and diabetes. Microstent eyes had on average 1.00 (standard deviation 2.32) fewer visits compared with trabeculectomy eyes in the first month (P < 0.001), adjusted for baseline characteristics. The percentage of eyes that had lost >2 lines of vision at last follow-up or reoperation was 12.4% (95% CI, 8.0%-18.7%) and was 21.9% (95% CI, 15.3%-30.1%) adjusted (P = 0.0383). A higher proportion of microstent eyes regained their baseline preoperative visual acuity compared with trabeculectomy eyes (log-rank P = 0.0250; adjusted HR, 1.46 [95% CI, 1.10-2.00]). Altogether, 25.3% (95% CI, 15.3%-38.9%) of microstent eyes and 40.7% (95% CI, 27.7%-55.3%) of trabeculectomy eyes had > 0.5 D surgically induced astigmatism on an adjusted basis; 8.0% (95% CI, 3.2%-18.6%) vs. 17.3% (95% CI, 8.9%-9.8%) had >1 D. CONCLUSIONS: Microstent eyes had more TCNRs (though fewer in-clinic interventions), fewer postoperative visits, and less vision loss, and experienced less surgically induced astigmatism, than trabeculectomy eyes. Overall, the postoperative course was less intensive for the microstent, except for more TCNRs.

Consecutive case series of 244 age-related macular degeneration patients undergoing implantation with an extended macular vision IOL.

PURPOSE: To determine safety and visual outcomes in eyes with age-related macular degeneration (AMD) implanted with a novel intraocular lens (IOL) that delivers an optimized retinal image to all macular areas within 10 degrees of retinal eccentricity. METHODS: This was a consecutive case series of 244 eyes with dry/stable wet AMD and logMAR visual acuity ≥0.3 implanted with iolAMD Eyemax monoTM (London Eye Hospital Pharma), a single-piece, injectable, hydrophobic acrylic IOL sited in the capsular bag. Primary outcome was safety. Secondary outcomes were changes in corrected distance visual acuity (CDVA) and corrected near visual acuity (CNVA) (logMAR). RESULTS: Mean age at surgery was 80 years. Mean duration of follow-up was 3 months (range 1-16 months). No eyes had worsening of CDVA. Frequency of perioperative complications was equivalent to standard IOL implantation. Postoperative refractive outcomes were within ±1 D of the target refraction in 88% of cases. Mean preoperative CDVA improved from 1.06 to 0.71 postoperatively (mean of differences -0.35; 95% confidence interval [CI] -0.3886 to -0.3223; p<0.0001), equating to an approximate Early Treatment Diabetic Retinopathy Study gain of 18 letters. Mean preoperative CNVA (N-point; logMAR conversion) improved from 1.36 to 0.88 postoperatively (mean of differences -0.48; 95% CI -0.53 to -0.44; p<0.0001). CONCLUSIONS: This novel IOL appears safe in the short to medium term. Improvements in postoperative CDVA and CNVA exceed those observed with standard implants.

First Results of a New Hyperaspheric Add-on Intraocular Lens Approach Implanted in Pseudophakic Patients with Age-Related Macular Degeneration.

PURPOSE: To determine the visual outcomes of the EyeMax Mono intraocular lens (IOL) technology (London Eye Hospital Pharma, London, UK), which is a foldable and injectable hydrophobic acrylic IOL implanted as an add-on solution in pseudophakic eyes with age-related macular degeneration, in a pilot study. DESIGN: A prospective, interventional case series. PARTICIPANTS: A total of 22 pseudophakic eyes (11 patients) with bilateral severe or intermediate dry age-related macular degeneration (AMD) (13 eyes) or stable wet AMD or disciform scarring (9 eyes) meeting the criteria for sulcal IOL implantation. METHODS: Both eyes of participating subjects underwent small-incision ciliary sulcal implantation of a hyperaspheric, soft hydrophobic acrylic intraocular lens designed to improve the quality of the retinal image in all areas of the macula ≤10° from fixation and to generate a moderate hypermetropic correction for magnification. MAIN OUTCOME MEASURES: The primary outcome was safety as determined by intra- and postoperative complications, raised intraocular pressure requiring medical or surgical intervention, postoperative diplopia, reduction in visual field, and loss of ≥2 lines of visual acuity. Secondary outcomes were improvements in subjective and objective visual acuity (logarithm of the minimum angle of resolution). RESULTS: No intraoperative complication occurred. Elevated intraocular pressure values were measured directly after the operative procedure in 2 eyes (25 mmHg and 27 mmHg) and at the 1-week postoperative visit in 1 eye (22 mmHg) but not later. The mean postoperative spherical equivalent of refraction changed to +2.5 diopters, and all eyes had gained ≥2 lines of visual improvement (corrected distance visual acuity) by 6 months after surgery. Corrected near visual acuity as well as corrected distance visual acuity improved over time, suggesting a neuroadaptive component to improved visual function with the device. Devices were implanted bilaterally in all patients, and there were no reported symptoms of dysphotopsia or diplopia. CONCLUSIONS: Safety concerns were not identified in the short-term or medium term. These results indicate the potential of the EyeMax Mono IOL to improve near and distance visual acuity in pseudophakic eyes with intermediate to severe AMD.

[Pseudophacic additive lenses]. / Pseudophake additive Intraokularlinsen.

Implantation of artificial intraocular lenses (IOL) after cataract removal today represents the standard of care in the field of anterior segment surgery. In refractive lens exchange cases the natural lens is replaced by an IOL to correct different types of refractive situations. In the majority of the operations the refractive result is satisfying with only few deviations from target refraction.But daily practice reveals some outliers from the intended corrections with the need for further refractive enhancements, respectively. Especially odd eyes with short or long axial length, corneal astigmatism, ceratoconus or after corneal laser vision correction are more or less candidates for refractive surprises. Laser corneal surgery and additional intraocular implants are both established surgical approaches to achieve this goal in pseudophacic eyes. In paediatric cataract surgery for congenital cataracts implantation of add-on lenses can be helpful to adjust refraction according to eyeball development and prevent amblyopia.This article presents an overview about currently available implants and techniques using additional lenses to correct residual refractive errors. Furthermore, new implants for special indications like macular degeneration are addressed. A thorough evaluation of risk and benefit for each patient group and materials used are provided.

Femtosecond Laser-Assisted Capsulotomy: Histological Comparison of Four Different Laser Platforms.

PURPOSE: To compare histological analyses of capsulotomies from different laser systems with regard to tissue alteration, laser spot formation, and energy settings. METHODS: Four femtosecond laser platforms approved for cataract surgery were evaluated: LenSx (Alcon Laboratories, Inc., Fort Worth, TX), Catalys (Abbott Medical Optics, Santa Ana, CA), Victus (Tecnolas/Bausch & Lomb, Munich, Germany), and LensAR (Topcon, Gamagori, Japan). Ten human anterior lens capsulotomy disks from each laser system were analyzed: five by means of light microscopy and five by transmission electron microscopy (TEM). TEM was used especially to examine the cellular and stromal changes at the cutting edges. The cellular demarcation line was measured at 15 points along the rim and statistically compared with the findings from all laser platforms. Three capsules of each laser platform were prepared for TEM to evaluate the cellular and tissue edges of the laser cuttings. RESULTS: All capsulotomies revealed a circular demarcation zone of different sizes along the cutting edges. Light microscopy showed a radial tissue damage of 36.0 ± 12.3 µm after Victus laser capsulotomy, 8.9 ± 2.9 µm after Catalys laser capsulotomy, 25.2 ± 5.6 µm after LensAR laser capsulotomy, and 39.8 ± 5.1 µm after LenSx laser capsulotomy. Differences between the damaged tissue zones correlated with the laser systems and their energy settings. CONCLUSIONS: The use of less energy and larger spot separation led to smaller collateral damaged tissue areas along the cutting edges. The aberrant laser spots along the cutting edge may result in weakening of the remaining tissue, thereby enhancing the risk for capsular ruptures during surgery. [J Refract Surg. 2017;33(10):670-675.].

Ab Interno Gel Implant for the Treatment of Glaucoma Patients With or Without Prior Glaucoma Surgery: 1-Year Results.

PURPOSE: The purpose of this study is to evaluate IOP lowering effects and complication management of an ab interno gel implant for the treatment of patients refractory to antiglaucoma medication or glaucoma surgery. METHODS: Retrospective analysis of the medical records of 242 consecutive eyes of 146 patients with uncontrolled intraocular pressure (IOP) despite maximum tolerated medical therapy or prior surgical intervention that underwent XEN45 implantation (as sole procedure or in combination with cataract surgery) between March 2014 and June 2015. Data included IOP, number of glaucoma medications, the need for additional surgery, needling, and complications. RESULTS: During the study period, mean IOP had decreased by 54.1% from 32.19 (±9.1) mm Hg to 14.24 (±4.0) mm Hg (P=0.00; Wilcoxon test). The number of antiglaucoma medications had decreased from a mean of 3.13±1.0 to 0.3±0.7 (P=0.00; Wilcoxon test). Needling was required between week 1 and months 3 in 27.7% of all eyes to enhance the outflow. Hypotony (IOP<6 mm Hg) was observed in 9 eyes (4.0%) at 1 month but normalized in all eyes at 12 months postoperatively. Two eyes experienced hypotony requiring the refill of the anterior chamber. CONCLUSIONS: Our data indicate that the XEN45 gel implant has a favorable safety profile and is an effective treatment option for controlling IOP in glaucoma patients with unregulated IOP despite IOP lowering medical therapy or prior surgical intervention. It offers an effective approach, both as sole procedure and in combination with cataract surgery.

[Refractive Lens Exchange]. / Refraktiver Linsenaustausch.

In refractive surgery the removal of the natural lens followed by implantation of an artificial intraocular lens has been an established method to treat refractive errors. The term "clear lens exchange" separates this approach from cataract surgery, where a cloudy lens has to be removed. With regard to currently available intraocular lens technologies, there is a wide range to correct myopia, hyperopia as well as astigmatism. Trifocal or extended depth-of-focus lenses (EDOF) even with a toric component offer the patients a potential benefit to further address presbyopia, respectively. Furthermore, the surgery in combination with Femtosecond laser-assistance offers more precision to this highly elective approach.This article provides an overview about currently available procedures and implants to correct presbyopia and refractive errors. A thorough evaluation of risk and benefit for each patient group is given with regard to recent guidelines of the German Commission for Refractive Surgery (KRC).

Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy.

PURPOSE: To compare the efficacy, safety, and risk factors for failure of standalone ab interno gelatin microstent implantation with mitomycin C (MMC) versus trabeculectomy with MMC. DESIGN: International, multicenter, retrospective interventional cohort study. PARTICIPANTS: Three hundred fifty-four eyes of 293 patients (185 microstent and 169 trabeculectomy) with no prior incisional surgery. METHODS: Consecutive eyes with uncontrolled glaucoma underwent microstent or trabeculectomy surgery from January 1, 2011 through July 31, 2015 at 4 academic ophthalmology centers: Toronto, Canada; Frankfurt, Germany; Salzburg, Austria; and Leuven, Belgium. MAIN OUTCOME MEASURES: Primary outcome measure was hazard ratio (HR) of failure, with failure defined as 2 consecutive intraocular pressure (IOP) readings of <6 mmHg with vision loss or >17 mmHg without glaucoma medications (complete success) at least 1 month after surgery despite in-clinic interventions (including needling). Secondary outcome measures included IOP thresholds of 6 to 14 mmHg and 6 to 21 mmHg and same thresholds allowing for medications (qualified success), interventions, complications, and reoperations. RESULTS: Baseline characteristics were similar, except more men (56% vs. 43%), younger patients (average, by 3 years), better preoperative visual acuity (22% vs. 32% with 0.4 logarithm of the minimum angle of resolution vision or worse), and more trabeculoplasty (52% vs. 30%) among microstent eyes. The adjusted HR of failure of the microstent relative to trabeculectomy was 1.2 (95% confidence interval [CI], 0.7-2.0) for complete success and 1.3 (95% CI, 0.6-2.8) for qualified success, and similar for other outcomes. Time to 25% failure was 11.2 months (95% CI, 6.9-16.1 months) and 10.6 months (95% CI, 6.8-16.2 months) for complete success and 30.3 months (95% CI, 19.0-∞ months) and 33.3 months (95% CI, 25.7-46.2 months) for qualified success. Overall, white ethnicity was associated with decreased risk of failure (adjusted HR, 0.49; 95% CI, 0.25-0.96), and diabetes was associated with increased risk of failure (adjusted HR, 4.21; 95% CI, 2.10-8.45). There were 117 and 165 distinct interventions: 43% and 31% underwent needling, respectively, and 50% of trabeculectomy eyes underwent laser suture lysis. There were 22 and 30 distinct complications, although most were transient. Ten percent and 5% underwent reoperation (P = 0.11). CONCLUSIONS: There was no detectable difference in risk of failure and safety profiles between standalone ab interno microstent with MMC and trabeculectomy with MMC.

Phake Intraokularlinsen.

Implanting phakic IOLs (PIOLs) in phakic eyes is regarded as an established option in refractive surgery for many years when treating high myopia, hyperopia or ametropia. Even for eyes which show a combination of refractive errors (including astigmatism) this can be an appropriate option. The surgery itself requires certain anatomical and refractive requirements, since, as with any intraocular procedure, there are different possibilities of complication depending on the chosen IOL. Therefore, any potential candidate for refractive surgery should be treated in accordance with the current recommendations of the German "Commission Refractive Surgery" (KRC) to achieve the best possible refractive outcome with maximum safety for patient and surgeon.This article will present the current options for surgery and IOLs with special focus on possibilities and limitations.

Clinical Evaluation of Macular Thickness Changes in Cataract Surgery Using a Light-Adjustable Intraocular Lens.

PURPOSE: To detect changes in retinal perfusion and macular thickness using fluorescein angiography and spectral-domain optical coherence tomography (OCT) before and after implantation of a Calhoun light-adjustable intraocular lens (Calhoun Vision, Pasadena, CA) and application of profiled doses of ultraviolet light for postoperative refractive adjustments. METHODS: This prospective trial of non-consecutive cases comprised 125 eyes of 125 patients who had cataract surgery and light-adjustable intraocular lens implantation. OCT examinations were performed preoperatively and postoperatively before first adjustment (10 to 14 days postoperatively) and 1 week (20 to 25 days postoperatively), 1 month (6 weeks postoperatively), 3 months (4 months postoperatively), and 12 months (13 months postoperatively) after lock-in. A control group of 104 eyes was evaluated for comparison. RESULTS: One hundred twenty-two eyes at 12 months postoperatively were included and analyzed. Despite a general increase in macular thickness measurements overall during the first postoperative weeks, no changes to the integrity of inner segment/outer segment junction, outer nuclear layer, external limiting membrane, or retinal pigment endothelium were detected. The neuroretina returned to baseline by 3 months after surgery and there was no significant difference between preoperative and postoperative measurements after 3-month thickness values. CONCLUSIONS: Ultraviolet light exposure for light-adjustable IOL adjustments did not influence the incidence of postoperative macular edema and did not induce any changes in the macular layers.