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.

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.

[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.

[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).

Initial clinical results of a new telescopic IOL implanted in patients with dry age-related macular degeneration.

PURPOSE: To evaluate the safety and efficacy of the iol-AMD technology (London Eye Hospital Pharma, London, UK), which includes two injectable, hydrophobic acrylic intraocular lenses (IOLs) in a pilot study of patients diagnosed as having cataract and dry age-related macular degeneration. METHODS: The cataract surgery and IOL implantation were performed after a preoperative evaluation using the iolAMD simulator in eyes with bilateral intermediate dry age-related macular degeneration. Outcomes were intraoperative and postoperative complications, subjective and objective visual acuity improvement, visual field changes, and postoperative diplopia. RESULTS: Three eyes of 2 patients were evaluated. The surgeries were uneventful. All eyes gained monocular reading vision at the 1-week postoperative visit. One patient with monocular implantation recognized diplopia for distance vision. Preoperative corrected distance visual acuity ranged from 20/800 to 20/125 and corrected near visual acuity was 20/800 or less. Two months after surgery, corrected distance and near visual acuities increased to levels between 20/40 and 20/25 (uncorrected distance visual acuity was 20/60 to 20/32; uncorrected near visual acuity was 20/200 to 20/25). CONCLUSIONS: These early results showed that the iolAMD simulator is a promising technology improving near and distance visual acuity in eyes with intermediate dry macular degeneration. The prismatic IOL effect did not lead to diplopia when implanted bilaterally. The surgery was safely performed.

Intraindividual capsular bag shrinkage comparing standard and laser-assisted cataract surgery.

PURPOSE: To examine the dynamics of capsular bag changes over 3 months of healing after standard cataract surgery and laser-assisted cataract surgery. METHODS: One hundred six eyes of 53 patients with visually significant cataracts were treated with laser-assisted cataract surgery in one eye and standard phacoemulsification in the other. A capsular measuring ring was implanted in both eyes and effective phacoemulsification time was recorded. Capsular bag diameter was measured at six time points within 3 months of follow-up. Intraindividual capsular bag shrinkage was calculated. RESULTS: The laser group required less ultrasound energy to remove the softened nucleus than the standard group (effective phacoemulsification time: 0.03 vs 1.25 sec; P < .005). The laser group had statistically significantly less capsular bag shrinkage than the standard group at all time points from 1 to 3 months (P < .001). CONCLUSIONS: Lens position changes within 3 months postoperatively may be lessened with laser-assisted cataract surgery in comparison to standard phacoemulsification due the decreased capsular bag shrinkage during this period. A tendency toward earlier stabilization of the capsular bag diameter with laser-assisted cataract surgery provides potential for more predictable effective lens position and intraocular lens power calculations.

Femtosecond laser-induced macular changes and anterior segment inflammation in cataract surgery.

PURPOSE: To compare femtosecond laser-assisted cataract surgery with standard phacoemulsification concerning the incidence of postoperative clinical or subclinical macular edema and the correlation between macular thickness and postoperative intraocular inflammation values. METHODS: One hundred four eyes of 104 patients were treated by laser-assisted cataract surgery and the fellow 104 eyes underwent phacoemulsification using pulsed ultrasound energy and intraocular lens implantation in this prospective randomized study. Laser flare photometry was measured preoperatively and at 2 hours, 3 to 4 days, 1 month, 3 months, and 6 months postoperatively. Retinal thickness was measured by spectral-domain optical coherence tomography. RESULTS: Two hundred two eyes (97%) were included and analyzed at 6 months postoperatively. The mean center thickness in the laser group was 210 ± 24 µm at 4 days postoperatively, 214 ± 22 µm at 1 month postoperatively, 219 ± 20 µm at 3 months postoperatively, and 215 ± 22 µm at 6 months postoperatively. The mean center thickness in the standard group was 211 ± 32 µm at 4 days postoperatively, 210 ± 34 µm at 1 month postoperatively, 217 ± 29 µm at 3 months postoperatively, and 209 ± 30 µm at 6 months postoperatively. Laser flare photometry showed higher levels in the standard group at the first postoperative visit 2 hours after surgery compared with the laser group. CONCLUSIONS: Femtosecond laser-assisted cataract surgery did not obviously influence the incidence of postoperative macular edema.

Cortex removal after laser cataract surgery and standard phacoemulsification: a critical analysis of 800 consecutive cases.

PURPOSE: To evaluate the ease of anterior cortex removal and hydrodissection of the lens in femtosecond laser-assisted cataract surgery compared with standard phacoemulsification. METHODS: In the femtosecond laser-assisted cataract surgery group (400 eyes), a femtosecond laser was used for capsulotomy and followed by lens fragmentation. In the standard group, the capsulorhexis was performed manually. In both groups, a normal hydrodissection was set, the nucleus was aspirated with or without ultrasound phacoemulsification energy, and residual cortex removal and posterior capsule polishing were performed using bimanual irrigation/aspiration. The primary end point was the time (in seconds) required for the removal of the cortex from instrument insertion in the eye until aspiration tip removal. Secondary end points were the effective phacoemulsification time, quality of the anterior capsule, and anterior or posterior capsule ruptures. RESULTS: Cortex removal time measured 30 ± 13 seconds (range: 10 to 76 seconds) for the standard group and 27 ± 10 seconds (range: 9 to 72 seconds) for the femtosecond laser-assisted cataract surgery group (P < .005). After laser-assisted capsulotomy, one capsule was still adherent following removal by forceps. No anterior or posterior capsular tears were observed in either group. CONCLUSIONS: In femtosecond laser-assisted cataract surgery, the biaxial cortex removal time was comparable with the time in standard phacoemulsification.

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.

Effect of femtosecond laser fragmentation on effective phacoemulsification time in cataract surgery.

PURPOSE: To compare the effect of femtosecond laser-assisted cataract surgery on effective phacoemulsification time (EPT) with standard cataract surgery. METHODS: This prospective clinical trial evaluated the feasibility of using a femtosecond laser system (Catalys Precision Laser System, OptiMedica) to perform capsulotomy and lens fragmentation in the treatment of patients with senile cataract. Patients were evaluated preoperatively with the Lens Opacities Classification System III (LOCS III). Fifty-two patients underwent standard cataract surgery and 57 patients underwent femtosecond laser-assisted cataract surgery in December 2011. Both groups underwent phacoemulsification using pulsed ultrasound energy and EPT was evaluated. RESULTS: Preoperative LOCS III grades were 3.4±0.9 in the femtosecond laser-assisted cataract surgery group and 3.1±0.9 in the standard group. In the femtosecond laser-assisted cataract surgery group, mean laser treatment time was 54.9 seconds and EPT was 0.16±0.21 seconds compared to 4.07±3.14 seconds in the standard group. CONCLUSIONS: The use of the femtosecond laser-assisted system in cataract surgery led to a lower EPT compared to the standard procedure.

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.

Clinical evaluation of an ultraviolet light adjustable intraocular lens implanted after cataract removal: eighteen months follow-up.

PURPOSE: To determine the effectiveness of a light-adjustable intraocular lens (LAL) that can be adjusted postoperatively using ultraviolet (UV) irradiation. DESIGN: A prospective, nonrandomized clinical trial was conducted at Center for Vision Science, Ruhr University Eye Clinic, in Bochum, Germany. PARTICIPANTS: We included 122 eyes of 91 patients with significant cataract. METHODS: All patients had a visually significant cataract and were willing to volunteer for the trial. Participants underwent small-incision phacoemulsification followed by implantation of a LAL and were treated with a spatially profiled UV light delivered by a digital light delivery device to induce a targeted spherical and cylindrical refractive change postoperatively. Once the desired correction was achieved, the LAL was treated again to lock in the lens power. Distance visual acuity and manifest refraction was determined with follow-up time to determine the achieved refractive corrections and their stability. MAIN OUTCOME MEASURES: We measured uncorrected visual acuity and best corrected visual acuity achieved versus targeted refractive outcome and refractive stability with a follow-up time of 18 months. RESULTS: Residual postoperative refractive errors of 0.96 ± 0.85 diopters (D) in sphere and -0.98 ± 0.50 D in cylinder were corrected and stable over a follow-up time of 18 months. Final refraction achieved was 0.03 ± 0.17 D in spherical equivalent refraction. CONCLUSIONS: Residual spherocylindrical errors up to 2.25 D in sphere and -2.75D in cylinder were successfully corrected with precision. The LAL technology has the potential individually to correct postoperative refractive errors precisely. The achieved refractive corrections are stable for up to 18 months. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any of the materials discussed in this article.

Combined correction of axial hyperopia and astigmatism using the light adjustable intraocular lens.

PURPOSE: To determine whether residual spherical and cylindrical errors could be corrected postoperatively using spatially profiled UV light irradiation in patients with axial hyperopia undergoing cataract surgery and implantation of a light adjustable, silicone intraocular lens (LAL). DESIGN: We conducted a prospective, nonrandomized clinical trial. The LALs were implanted in eyes with axial lengths <22.20 mm and were treated with a spatial intensity profile delivered by a digital light delivery device to induce a targeted spherical and cylindrical refractive change postoperatively. Once the desired correction was achieved, the LAL was treated again to lock-in the lens power. PARTICIPANTS: We studied 15 eyes of 15 patients with axial hyperopia. METHODS: The manifest refraction, uncorrected visual acuity (UCVA), and best spectacle-corrected visual acuity (BCVA) were determined with follow-up time of 12 months to determine the achieved refractive corrections and their stability. MAIN OUTCOME MEASURES: We measured UCVA, BCVA, achieved versus targeted refractive outcome, and refractive stability with a follow-up time of 12 months. RESULTS: Of 15 eyes, 14 (93%) achieved ± 0.5 diopters (D), and 10 (67%) were within ± 0.25 D of the targeted refractive adjustment up to 12 months postoperative follow-up. Only 1 treated eye showed a change of 0.38 D in manifest spherical equivalent refraction, the remaining 14 eyes showed <0.25 D change between 1 month post lock-in, and at the 3-, 6-, and 12-month postoperative visits. CONCLUSIONS: The light-adjustable lens is a promising technology with the potential to reduce the rate of postoperative refractive surprises up to 2 D of spherical and cylindrical errors after cataract surgery. Postoperative refractive errors were successfully corrected with precision and significant improvement in UCVA and without compromising BCVA using the light-adjustable intraocular lens technology. The data demonstrate the stability of the achieved refractive change after the adjustment and lock-in procedures.

Evaluation of the Calhoun Vision UV Light Adjustable Lens implanted following cataract removal.

PURPOSE: To evaluate the effectiveness of a silicone intraocular lens (IOL) that can be adjusted following implantation using ultraviolet (UV) irradiation. METHODS: Prospective clinical trial of 40 patients (40 eyes) with visually significant cataract. Participants underwent small-incision phacoemulsification followed by implantation of a light-adjustable, silicone IOL (Light Adjustable Lens [LAL], Calhoun Vision). All patients were required to wear UV-protective eyewear at all times, until final lock-in. Pre- and postoperative clinical parameters included distance visual acuity and manifest refraction. RESULTS: At average 2 weeks postoperative (range: 10 to 21 days), patients were seen and refracted to determine type and magnitude of refractive error needing correction. All patients required an initial adjustment of the LAL, whereas 28 required a second UV treatment and none required a third adjustment. At 4 months postoperative, mean refraction was 0.04±0.37 diopters (D) (range: -0.88 to 0.50 D), mean sphere was 0.24±0.40 D (range: -0.50 to 0.75 D), and mean cylinder was 0.41±0.25 D (range: 1.00 to 0.0 D). Eighty-one percent of eyes gained 2 or more lines of corrected distance visual acuity. CONCLUSIONS: The adjustment and lock-in procedures were well tolerated by patients. The Calhoun Vision LAL is a promising technology with the potential to eliminate postoperative refractive surprises of up to 2.00 D of refractive and cylindrical error following implantation.

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).

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).