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.

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.

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.

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.

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.