Ten-Year Effectiveness and Safety of Trabecular Micro-Bypass Stent Implantation with Cataract Surgery in Patients with Glaucoma or Ocular Hypertension.

INTRODUCTION: This study evaluated 10-year results of implanting one iStent trabecular micro-bypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. METHODS: This retrospective, non-randomized study examined 10-year outcomes of iStent trabecular micro-bypass stent implantation with cataract surgery by one surgeon in eyes with OAG [including primary OAG (POAG) and pseudoexfoliative glaucoma (PXG)] or ocular hypertension at a multi-specialty German ophthalmology center. Study visits were conducted preoperatively and at 2.5, 3, 5, and 10 years postoperatively; examinations included intraocular pressure (IOP), medications, corrected-distance visual acuity (CDVA), and adverse events. RESULTS: A total of 63 eyes of 45 patients with OAG (n = 60 eyes) or ocular hypertension (n = 3 eyes) and data through 10 years were analyzed. Mean preoperative IOP was 18.6 ± 4.4 mmHg on 1.83 ± 1.03 mean medications. At study visits through 10 years postoperative, mean IOP reduced by 12.9-19.0% (p < 0.005 at all points), and mean medication burden reduced by 37.8-51.4% (p ≤ 0.006 at all points). At 10 years postoperatively, 77.8% of eyes had IOP ≤ 18 mmHg and 47.6% had IOP ≤ 15 mmHg (vs. 50.8% and 25.4% preoperatively, respectively; p = 0.016). One-third (33.3%) of eyes were medication-free vs. 3.2% preoperatively (p < 0.001); 17.5% were on 2-5 medications (vs. 55.6% preoperatively, p = 0.005); and 93.7% of eyes were on the same or fewer medications vs. preoperative. Post-phacoemulsification CDVA improvement was maintained; no filtering surgeries were completed over 10-year follow-up. CONCLUSIONS: Significant and safe IOP and medication reductions were observed through 10 years after iStent implantation with cataract surgery in patients with OAG or ocular hypertension.

Laser-integrated real-time OCT in anterior segment procedures.

Intraoperative optical coherence tomography (OCT) was so far only available as a microscope-integrated or handheld device. Recently, this technology has been integrated into a femtosecond (FS) laser. This pilot study analyzed the potential of intraoperative imaging using OCT during FS-assisted procedures of the anterior eye segment. Therefore, intraoperatively acquired videos using FS-integrated intraoperative OCT (laser-integrated [LI] OCT) in 14 patients (Victus, Bausch & Lomb) were analyzed in different surgical procedures. The results showed that all surgical steps could be successfully visualized by LI-OCT. LI-OCT added important information regarding the depth and location of the incisions and dissection planes. Moreover, dynamic processes could be observed in real-time. LI-OCT represents a new imaging technology that makes it possible to visualize intraoperative steps during FS-assisted surgery. In the future, automatic image analysis based on artificial intelligence could be helpful to detect complications at an early stage and to automatically stop the laser process in relevant constellations.

Second-generation trabecular micro-bypass stent implantation: Retrospective analysis after 12- and 24-month follow-up.

BACKGROUND: The study aimed to investigate the 24-month safety and efficacy of implantation of two second-generation iStent inject trabecular micro-bypass stents with concomitant cataract surgery. METHODS: This consecutive case series included 164 eyes of 109 patients implanted with the iStent inject® device with concomitant cataract surgery. The series was comprised of eyes with primary open-angle glaucoma (n = 84), pseudoexfoliation glaucoma (n = 42), normal-tension glaucoma (n = 18), and ocular hypertension (n = 20). All 164 eyes reached 9-14 months of follow-up ("12-month consistent cohort"), with a subset of 88 eyes reaching 21-26 months of follow-up ("24-month consistent cohort"). Performance outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included intra- or postoperative complications, the need for secondary procedures and corrected distance visual acuity. Comparisons of change in continuous (e.g., IOP) and categorical (e.g., proportions of eyes on zero medications) measures between baseline and postoperative times were made with the paired t-test and McNemar's chi-squared test, respectively. RESULTS: At 12 months postoperatively, IOP was reduced by 25.5% (from 20.0 ± 5.5 mmHg to 14.9 ± 2.0 mmHg; p < 0.001); at 24 months postoperatively, IOP was reduced by 26.6% (from 20.3 ± 6.1 mmHg to 14.9 ± 1.9 mmHg; p < 0.001). At 12 months postoperatively, mean number of glaucoma medications was reduced by 85.0% (from 2.0 ± 1.0 to 0.3 ± 0.8 medications; p < 0.001); at 24 months postoperatively, mean number of medications was reduced by 81.0% (from 2.1 ± 1.1 to 0.4 ± 0.8 medications; p < 0.001). After 12 months, 96.3% of eyes had an IOP ≤ 18 mmHg and 58.5% of eyes had an IOP ≤ 15 mmHg, with 81.1% of eyes free of any medication, compared to 1.8% of eyes medication-free in the 12-month cohort at baseline. After 24 months, 98.9% of eyes had an IOP ≤ 18 mmHg and 53.4% of eyes had an IOP ≤ 15 mmHg, with 72.7% free of medication compared to 1.1% of eyes medication-free in the 24-month cohort at baseline. Overall, a high safety profile was observed with no significant postoperative complications. CONCLUSIONS: The insertion of iStent inject (comprised of two second-generation trabecular micro-bypass stents) with cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden up to 24 months postoperatively.

Long-term effectiveness and safety of trabecular microbypass stent implantation with cataract surgery in patients with glaucoma or ocular hypertension: Five-year outcomes.

PURPOSE: To assess 5-year outcomes after implantation of 1 trabecular microbypass stent during cataract surgery in eyes with open-angle glaucoma (OAG) or ocular hypertension. SETTING: Private ophthalmology clinic (AaM Augenklinik am Marienplatz, Munich, Germany). DESIGN: Prospective nonrandomized consecutive case series. METHODS: One trabecular microbypass stent was implanted after phacoemulsification cataract surgery by one surgeon over 4 years. Evaluations included intraocular pressure (IOP), medications, corrected distance visual acuity, cup-to-disc ratio, complications, and adverse events. RESULTS: This case series included 65 eyes of 43 patients with OAG (including primary, n = 39; pseudoexfoliative, n = 14; secondary uveitic, n = 1; posttraumatic, n = 1) or ocular hypertension (n = 10). Thirty-eight percent of eyes had previous trabeculectomy and/or glaucoma laser procedures, and 68% were on 2 or more preoperative medications. Twenty-six eyes completed follow-up through 5 years, and follow-up is ongoing. Among eyes without additional glaucoma surgery, the mean year 5 IOP decreased by 38% to 14.7 mm Hg ± 3.0 (SD) versus 23.7 ± 7.4 mm Hg preoperatively; 92% of eyes had a mean year 5 IOP of 18 mm Hg or lower and 65% had an IOP of 15 mm Hg or lower. Medications were reduced by 75% to 0.5 ± 0.9 medications versus 2.0 ± 1.0 preoperatively, with 4% of eyes on 3 to 4 medications versus 28% preoperatively, and 69% medication-free versus 5% preoperatively. The mean IOP at all postoperative visits was 16.0 mm Hg or lower and the mean medication number was 0.5 or less. Safety was favorable throughout the follow-up. CONCLUSIONS: In a real-life cohort of eyes with OAG or ocular hypertension, substantial, durable, and safe IOP and medication reductions were achieved through 5 years after trabecular microbypass stent implantation with cataract surgery.

Anterior haptic flexing and in-the-bag subluxation of an accommodating intraocular lens due to excessive capsular bag contraction.

UNLABELLED: We describe the case of a patient who had cataract surgery with implantation of the hydrophilic acrylic Tetraflex accommodating intraocular lens (IOL), with subsequent development of capsulorhexis phimosis and in-the-bag IOL subluxation. Contraction of the capsular bag secondary to fibrosis resulted in significant anterior flexing of the lens haptic component. Explantation of the IOL-capsular bag complex was required 7 years after implantation. Histopathologic analysis demonstrated multiple areas of thick anterior subcapsular fibrosis. Pseudoexfoliative material was present throughout the surface of the lens capsule. Intraocular lenses manufactured from hydrophilic acrylic material are highly flexible and may be more susceptible to capsule contraction, even in the absence of predisposing ocular and systemic conditions. This case highlights the importance of developing guidelines regarding patient screening and selection for the appropriate use of accommodating and other highly flexible IOLs. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results.

PURPOSE: To evaluate long-term safety and efficacy of iStent trabecular micro-bypass stent implantation during cataract surgery in patients with primary open-angle, pseudo-exfoliation glaucoma, ocular hypertension, or secondary or post-traumatic glaucoma. SETTING: AaM Augenklinik am Marienplatz, Munich, Germany. DESIGN: Prospective, open-label, non-randomized study. METHODS: Preoperative and postoperative evaluations included intra-ocular pressure (IOP), topical ocular hypotensive medication use, cup/disc ratio, corrected-distance visual acuity (CDVA), complications, and adverse events. RESULTS: A single trabecular micro-bypass stent was implanted through the same temporal, limbal incision used for cataract surgery via phacoemulsification in a consecutive series of 62 eyes of 43 patients. To date, a total of 41 eyes have been followed for 3 years postoperatively, whereas long-term postoperative follow-up on the remaining patients is ongoing. Mean preoperative IOP was 24.1 ± 6.9 mm Hg on a mean of 1.8 medications (±0.9). Analyses of eyes with no secondary surgical intervention showed mean IOP reduction to 14.8 ± 4.2 mm Hg at 12 months (n = 61), 14.5 ± 2.2 mm Hg at 24 months (n = 42), and 14.9 ± 2.3 mm Hg at 36 months (n = 39). Medications were eliminated in 74% of eyes at 36 months. Five eyes, 4 with previous glaucoma surgeries and 1 with pseudo-exfoliation syndrome, required additional glaucoma surgery after stent implantation. No intra-operative or postoperative complications typically seen with conventional glaucoma surgeries occurred after stent implantation. At 36 months, CDVA was 20/40 or better in 38 eyes (93%). CONCLUSION: Trabecular micro-bypass stent implantation during cataract surgery was safe and effective in patients with ocular hypertension or glaucoma as measured by a sustained reduction in IOP and medication use and an excellent safety profile through 3 years after surgery. FINANCIAL DISCLOSURES: Dr. Neuhann has no financial or proprietary interest in any material or method mentioned. Glaukos Corp. provided editorial assistance in the preparation of the manuscript.

Intrastromal femtosecond laser presbyopia correction: 1-year results of a multicenter study.

PURPOSE: To investigate functional outcomes of the INTRACOR femtosecond laser-based intrastromal procedure to treat presbyopia. METHODS: Sixty-three eyes from 63 presbyopic patients (median age: 54 years) with mild hyperopia were enrolled in this prospective, ethics committee-approved, multi-center, nonrandomized clinical trial. The INTRACOR procedure was performed using the Technolas femtosecond laser (Technolas Perfect Vision GmbH) in the nondominant eye. Postoperatively, follow-up was performed at 1 day, 1 week, and 1, 3, 6, and 12 months and included near and distance visual acuity tests, slit-lamp examinations, and corneal topography. RESULTS: All 63 surgeries were uneventful. Twelve months postoperatively, outcomes of 58 (92.1%) eyes were available for evaluation. Median uncorrected distance visual acuity (0.1 logMAR [range: 0.5 to 0.0 preoperatively and 0.5 to -0.1 postoperatively]) and corrected distance visual acuity (CDVA) (0.0 logMAR [range: 0.2 to -0.2 preoperatively and 0.3 to -0.1 postoperatively]) remained stable. Median spherical equivalent changed from +0.63 diopters (D) preoperatively to 0.00 D postoperatively. Median uncorrected near visual acuity increased significantly from 0.7 logMAR (range: 1.0 to 0.2) preoperatively to 0.2 logMAR (range: 0.8 to -0.1) postoperatively and eyes gained a median of 4 lines (range: 1 to 9 lines). Losses of 2 lines of CDVA were noted in 7.1% of eyes. Ring cuts were faintly visible at 12 months. CONCLUSIONS: The INTRACOR presbyopia procedure showed good and stable visual acuity outcomes over 12-month follow-up but loss of CDVA occurred in 7% of eyes. Overall patient satisfaction with the procedure was approximately 80%. Short treatment time and maintained corneal surface integrity are advantages of this procedure.

International Values of Central Pachymetry in Normal Subjects by Rotating Scheimpflug Camera.

PURPOSE: In corneal refractive surgery, postoperative ectasia risk assessment routinely includes pachymetric analysis at the apex and thinnest point. We examined whether these data differ worldwide and constructed preliminary country-specific normative thresholds. DESIGN: This was a multicenter, cross-sectional study. METHODS: Using the Pentacam Eye Scanner (OCULUS GmbH, Wetzlar, Germany), we examined 1 randomly selected eye from each of 555 normal adults (8 countries, 6 continents), measuring the thinnest point location, central pachymetry (thinnest point, pupillary center, and apex), and the apex-thinnest point difference. International differences were assessed by 1-way analysis of variance. Normative thresholds were defined by 2- and 3-SD gates or Tukey method. RESULTS: The thinnest point averaged 0.44 mm temporal and 0.29 mm inferior to the apex. Individual thinnest points located more than 1.0 mm inferior represented fewer than 0.5% of normal corneas (>0.76 mm in the US subgroup). The mean thinnest-point pachymetry was 536 µm overall, and values less than 469 or 435 µm (-2 or -3 SD, respectively) would be expected in less than 2.5% or 0.15% of normal corneas, respectively. The thinnest-point pachymetry averaged 2 to 3 µm thinner than apical (range, 0-32 µm). Differences of greater than 8.5 µm would be expected in less than 0.5% of normal corneas overall. CONCLUSIONS: International differences were largely clinically insignificant. Nevertheless, it remains preferable to establish racial/geographic-specific normative values. We defined preliminary generalized and country-specific thresholds useful to the corneal refractive surgeon for identifying potentially abnormal corneas based on common pachymetric parameters, particularly the thinnest point by tomography.

In-the-bag capsular tension ring and intraocular lens subluxation or dislocation: a series of 23 cases.

OBJECTIVE: To describe clinical and pathologic findings from cases of in-the-bag capsular tension ring (CTR) and intraocular lens (IOL) subluxation or dislocation. DESIGN: Retrospective case series with clinicopathologic correlation. PARTICIPANTS: Twenty-three explanted subluxated/dislocated capsular bags containing a CTR and an IOL explanted in Europe and submitted in fixative to the Berlin Eye Research Institute. METHODS: Standard gross and light microscopy of specimens, complete histopathologic analyses of selected specimens done at the University of Utah, as well as questionnaire sent to explanting surgeons, and patient chart review, when available. MAIN OUTCOME MEASURES: Lens design, material, and abnormalities, capsular bag anomalies, patient demographic data, surgical dates, and presence or absence of known risk factors. RESULTS: Patients were aged 76.31 ± 8.24 years at explantation, which was performed 81.5 ± 32.2 months after implantation. The IOLs in these cases were 3-piece hydrophobic acrylic (N = 11), 1-piece hydrophobic acrylic (n = 6), 3-piece silicone (n = 4), or 1-piece hydrophilic acrylic (n = 2) designs; all CTRs were made of poly(methyl methacrylate). Available information on associated ocular conditions included pseudoexfoliation (n = 17), glaucoma (n = 4), vitrectomy/retina surgery (n = 3), and trauma (n = 1). Complete histopathologic assessment in 3 specimens showed signs consistent with pseudoexfoliation, without available history related to this condition in one of the cases. Moderate/severe degrees of Soemmering's ring formation and capsulorhexis phimosis were observed or reported in 13 and 11 specimens, respectively. Fourteen eyes were implanted and explanted by the same surgeon, with an interval of 92.7 ± 23.4 months between the procedures. His rate of explantation because of subluxation/dislocation was 0.76% of the CTRs implanted during the time considered. CONCLUSIONS: Explantation because of postoperative subluxation or dislocation of CTR-IOL-capsular bag complexes occurred approximately 6.8 years after implantation in this series, providing further evidence that a fine line exists between zonular insufficiency that can be stabilized with the CTR alone and that requiring further support. Analyses of large series may help to define common factors associated with this complication, as well as surgical planning and employment of various endocapsular support devices to enhance postoperative zonular stabilization.

International values of corneal elevation in normal subjects by rotating Scheimpflug camera.

PURPOSE: To examine whether clinically significant differences exist in corneal elevation data from a sampling of countries worldwide. SETTING: International multicenter. DESIGN: Evaluation of diagnostic test or technology. METHODS: One randomly selected eye of normal adults from 8 countries spanning 6 continents was examined using the Pentacam Eye Scanner. Anterior and posterior elevations were measured at the apex and thinnest point. Differences between countries were assessed by Kruskal-Wallis. Normative thresholds were defined according to the Tukey method. RESULTS: The study examined 1 eye of 555 patients. Median elevations were similar across countries. Upper limits of normal for collective international data were 3.5 µm, 6.0 µm, 7.5 µm, and 13.5 µm at the anterior apex, anterior thinnest point, posterior apex, and posterior thinnest point, respectively. These and country-specific thresholds were similar to normal values from previous data; however, country-specific thresholds flagged additional eyes in China, Egypt, and India. Those thresholds were 4.5 µm at the anterior thinnest point (China and Egypt), 7.4 µm at the posterior apex (India), and 11.0 µm and 12.0 µm at the posterior thinnest point (China and Egypt, respectively). CONCLUSIONS: In general, international variations were clinically insignificant; thus, current screening guidelines maintained their applicability. Notable exceptions were China, Egypt, and India, where country-specific thresholds may better reflect the test populations and minimize potential false negative results from screening. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.

Anterior chamber depth in normal subjects by rotating scheimpflug imaging.

PURPOSE: Anterior chamber depth (ACD) is an important preoperative parameter in anterior segment surgery. Several factors are known to influence ACD, including race and geography. Our purpose was to sample data from various countries to characterize differences in ACD worldwide and, if any, assess their level of clinical significance. SETTING: International, multicenter. METHODS: Cross-sectional study. Using the Pentacam Eye Scanner (OCULUS GmbH, Wetzlar, Germany), we analyzed ACD measurements from 1077 eyes of 568 normal adults from nine countries spanning six continents. Differences between countries were assessed by comparison of 95% confidence intervals and by ANOVA. Normative thresholds were constructed at three standard deviations (SD) above and below the mean. RESULTS: Mean ACD was 3.11 mm overall, ranging from 2.91 mm (New Zealand) to 3.24 mm (United States). The ACD among New Zealanders was significantly shallower (P < .0001) than that among Chinese, Egyptians, Germans, Indians, and Americans. The maximum difference in the mean ACDs was 0.33 mm, between New Zealand and the United States. The shallowest 0.15% of normal ACD values occurred below 2.04 mm overall, ranging from 1.69 mm (New Zealand) to 2.42 mm (United States). The deepest 0.15% of normal ACD values occurred above 4.18 mm overall, ranging from 4.03 mm (Saudi Arabia) to 4.35 mm (Brazil). CONCLUSIONS: ACD did not vary significantly in the countries studied, with the notable exception of New Zealand. Surgeons should anticipate a greater likelihood of a shallow ACD when evaluating patients from New Zealand. Clinical examination and direct measurement of ACD are recommended. Finally, deep ACD has limited clinical utility in screening for keratoconus.

Clinicopathologic correlation of capsulorhexis phimosis with anterior flexing of single-piece hydrophilic acrylic intraocular lens haptics.

UNLABELLED: We describe 2 cases in which patients with 4-looped single-piece hydrophilic acrylic intraocular lenses (IOLs) exhibited postoperative complications including capsulorhexis phimosis, decentration, tilt, hyperopic shift, and luxation leading to explantation of the IOL-capsular bag complex. The excessive capsule fibrosis led to anterior flexing of the IOL haptics in both cases, even in the presence of a capsular tension ring (CTR). Histopathological analyses revealed a thick fibrocellular tissue attached to the inner surface of the anterior capsules, corresponding to the anterior capsule opacification and folds. An amorphous substance was observed on the outer surface of the anterior capsule in the case with a CTR, suggesting pseudoexfoliation material. These and similar cases raise concerns about the postoperative behavior of highly flexible IOLs in the presence of excessive capsular bag fibrosis. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

LASIK for myopia and astigmatism using the SCHWIND AMARIS excimer laser: an international multicenter trial.

PURPOSE: To assess the efficacy, predictability, and safety of LASIK for the surgical correction of low to moderate myopia with astigmatism using the SCHWIND AMARIS excimer laser. METHODS: Six international study sites enrolled 358 eyes with a manifest refraction spherical equivalent (MRSE) from -0.50 to -7.38 diopters (D) (mean sphere: -3.13+/-1.58 D) with up to -5.00 D of astigmatism (mean: -0.69+/-0.67 D). All eyes underwent treatment with the nonwavefront-guided aspheric algorithm of the SCHWIND AMARIS excimer laser. All eyes were targeted for emmetropia. Refractive outcomes and corneal higher order aberrations were analyzed pre- and postoperatively. Visual quality was assessed using photopic and mesopic contrast sensitivity. Six-month postoperative outcomes are reported. RESULTS: At 6 months postoperative, the MRSE for all eyes was -0.21+/-0.20 D, and 96% (343/358) of eyes had MRSE within +/-0.50 D. Uncorrected visual acuity was 20/20 or better in 98% (351/358) of eyes, and no eyes lost 2 or more lines of best spectacle-corrected visual acuity. The total corneal higher order aberrations root-mean-square increased by 0.09 microm, spherical aberration increased by 0.08 microm, and coma increased by 0.04 microm postoperatively. Photopic and mesopic contrast sensitivity did not change 6 months postoperatively. CONCLUSIONS: Treatment of myopia with astigmatism using the SCHWIND AMARIS excimer laser is safe, efficacious, predictable, and maintains visual quality.

One-year follow-up of bag-in-the-lens intraocular lens implantation in 60 eyes.

PURPOSE: To report the feasibility and clinical results of implanting a bag-in-the-lens intraocular lens (IOL) designed to prevent posterior capsule opacification after cataract surgery. SETTING: Departments of Ophthalmology, University of Antwerp, Antwerp, Belgium, and University of Munich, Munich, Germany. METHODS: This prospective study comprised 63 eyes (55 patients; 7 children, 48 adults) scheduled for cataract surgery and bag-in-the-lens IOL implantation. A posterior curvilinear capsulorhexis the same size as the anterior capsulorhexis was created for IOL insertion. After surgery, lens epithelial cell (LEC) proliferation was documented every 6 months with a minimum follow-up of 12 months. RESULTS: Sixty of 63 eyes (95%) had implantation of the bag-in-the-lens IOL. Conversion to a conventional IOL was necessary in 2 cases. In 1 eye, postoperative luxation of the IOL into the vitreous occurred as a result of an oversized anterior and posterior capsulorhexis. Three eyes had early postoperative iris incarceration in the lens groove that required surgery. No LEC proliferation on the optic occurred during a mean follow-up of 22.7 months (range 12 to 64 months); LEC proliferation was confined to the peripheral capsular bag. CONCLUSION: Lens epithelial cell proliferation was mild and confined to the periphery of the capsular bag during follow-up, and the bag-in-the-lens IOL optic remained clear.