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The PAUL Glaucoma Implant (PGI) is a novel, valveless glaucoma drainage device that is distinguished from prevailing tube shunts by its compact plate and small lumen. However, clinical consensus is lacking on its real-world advantages. Thus, we conducted a systematic review to assess PGI surgical approaches, safety, and efficacy. A comprehensive literature search was performed using PubMed, Embase, Web of Science, and ClinicalTrials.gov. Single case reports were excluded. Twenty-six studies comprising 1143 eyes were included. The most common duration of follow-up was one year, and five studies were prospective. Median IOP reduction by last follow-up was 53.4% (range 27.7-66.2%), and glaucoma medication use decreased by 71.8% (42.3-94.6%). At an intraocular pressure (IOP) upper threshold of 21 mmHg, the median qualified success rate was 92.0% (80.0-100.0%), and complete success was 48.0% (24.0-73.3%); though criteria varied between studies. The most frequently reported complications were hyphema (10.0%), numerical hypotony (9.7%), and shallow anterior chamber (5.9%). Tube erosion occurred in 5.0% of cases overall, and in 9.8% of eyes in prospective studies. A single randomized controlled trial comparing the PGI to the Ahmed Glaucoma Valve in pediatric patients found noninferiority at 12 months, but was limited by sample size and generalizability. Four additional retrospective comparative studies (three versus Baerveldt, one versus Ahmed) showed no consistent advantages of the PGI. Substantial variation was also reported in PGI surgical techniques, including ripcord use, graft material, and adjunctive antifibrotics. While the PGI appears effective in lowering IOP and medication burden, current evidence is limited by retrospective designs, small cohorts, heterogeneous protocols, and short follow-up. Tube erosions were reported more often than historically seen with Baerveldt and Ahmed devices. Higher-quality, prospective comparative studies are needed to determine the long-term safety, efficacy, and optimal surgical approach for the PGI.

To describe 12-month intraocular pressure (IOP) and medication use outcomes following excisional goniotomy (EG) as a stand-alone procedure in eyes with medically uncontrolled glaucoma. This was a retrospective analysis of data from surgeons at 8 centers (6 US, 2 Mexico). Eyes with glaucoma undergoing standalone EG with a specialized instrument (Kahook Dual Blade, New World Medical, Rancho Cucamonga, CA) for IOP reduction and followed for 12 months postoperatively were included. Data were collected preoperatively, intraoperatively, and 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. The primary outcome was reduction from baseline in IOP, and key secondary outcomes included IOP-lowering medication reduction as well as adverse events. A total of 42 eyes were analyzed, of which 36 (85.7%) had mild to severe primary open-angle glaucoma (POAG). Mean (standard error) IOP at baseline was 21.6 (0.8) mmHg, and mean number of medications used at baseline was 2.6 (0.2). At 3, 6, and 12 months postoperatively, mean IOP reductions from baseline were 4.6 mmHg (22.3%), 5.6 mmHg (27.7%), and 3.9 mmHg (19.3%) (p≤0.001 at each time point). At the same time points, mean medications reductions of 0.7 (25.8%), 0.9 (32.6%), and 0.3 (12.5%) medications were seen (p<0.05 at months 3 and 6, not significant at month 12). Six eyes (14.3%) underwent additional glaucoma surgery during the 12-month follow-up period. Standalone EG with KDB can reduce IOP, and in many cases reduce medication use, through up to 12 months in eyes with mild to severe glaucoma. Statistically significant and clinically relevant reductions in IOP were seen at every time point. While the goal of surgery was not to reduce medication burden, mean medication use was significantly reduced at all but the last time point. In the majority of eyes, the need for a bleb-based glaucoma procedure was delayed or prevented for at least 12 months.

Objectives To describe the efficacy and safety of goniotomy with trabecular meshwork excision using the Kahook Dual Blade (KDB, New World Medical Inc., Rancho Cucamonga, CA) in patients with severe or refractory glaucoma. Methods This retrospective multicentre case series reports on 40 eyes with severe or refractory open-angle glaucoma that underwent standalone or combined KDB goniotomy and were followed for 12 months post-operatively in the United-States, Mexico and Switzerland. Surgical success was defined as an intraocular pressure (IOP) reduction ≥20% from baseline at 12 months, with fewer medications than preoperatively. Mean IOP and antiglaucoma medication reduction, probabilities of achieving an IOP ≤16 or 18 mmHg, and adverse events were also analysed. Results Mean IOP decreased from 18.1 ± 5.0 mmHg at baseline to 14.8 ± 3.7 mmHg at 12 months (18.2% reduction, P  < 0.001). Concomitantly, the mean number of glaucoma medications decreased from 2.5 ± 1.4 to 1.7 ± 1.2 (32% reduction, P  = 0.002). The proportion of eyes achieving an IOP reduction of more than 20% from baseline was 37.5% ( n  = 15) at 12 months. At 12 months, 67.5% and 82.5% achieved a medicated IOP ≤ 16 and ≤18 mmHg, respectively. No severe complications were reported. Conclusion Excisional goniotomy with KDB achieves a statistically significant IOP and antiglaucoma medication reduction in severe or refractory glaucoma over a period of 12 months. While its efficacy decreases with time, its favourable safety profile makes it a potentially useful primary or adjunctive procedure in high-risk eyes.

To characterize the clinical outcomes of a novel ab interno minimally invasive procedure with the STREAMLINE Surgical System for creation of incisional goniotomies and canal of Schlemm viscodilation in eyes with mild to severe primary open-angle glaucoma (POAG). In a prospective, single-arm, first-in-human case series, 20 eyes of 20 subjects with mild to severe POAG underwent creation of incisional goniotomies and canal of Schlemm viscodilation following phacoemulsification cataract extraction after washout of all intraocular pressure (IOP)-lowering medications. The angle surgery portion was performed with a single-use handpiece tipped with a microcannula that creates precise goniotomies through the trabecular meshwork into the canal of Schlemm and delivers a small volume of ophthalmic viscosurgical device directly into the canal via precise catheterization. Outcomes in this interim analysis included mean reduction in IOP and medications through 6 months of follow-up, as well as the proportion of eyes achieving IOP reduction ≥20% from baseline. At month 6, mean IOP reduction of ≥20% from baseline was achieved in 89.5% of eyes (17/19). Mean (standard deviation) medicated IOP at screening was 16.3 (3.6) mmHg and unmedicated baseline IOP (after washout) was 23.5 (2.5) mmHg. Mean IOP was significantly reduced from baseline through 6 months of follow-up to 14.7 (2.4) mmHg ( <0.001), representing an IOP reduction of 8.8 mmHg (36.9%). Overall, 57.9% (11/19) of eyes decreased dependence on IOP-lowering medications by at least one medication, and 42.1% (8/19) were medication free. Mean medication use was reduced from 2.0 (0.8) at screening to 1.1 (1.1) at 6 months ( <0.001). Three eyes had transient IOP spikes treated with topical medications. The creation of incisional goniotomies and canal of Schlemm viscodilation safely and effectively reduced IOP and the need for IOP-lowering medications by both clinically and statistically significant magnitudes in eyes with mild to severe POAG undergoing concomitant phacoemulsification cataract extraction through the first 6 months of follow-up.

To characterize clinical outcomes of transluminal dilation of the canal of Schlemm using the STREAMLINE Surgical System combined with phacoemulsification in eyes of Hispanic patients diagnosed with mild to moderate primary open-angle glaucoma. This was a prospective analysis of all cases performed and followed up to 12 months. All eyes underwent medication washout preoperatively. Reduction in intraocular pressure (IOP) from unmedicated baseline, as well as medications from pre-washout baseline, were analyzed at postoperative Day 1, Week 1, and Months 1, 3, 6, 9, and 12. All 37 patients were Hispanic, 83.8% were female, and mean (standard deviation) age was 66.0 (10.5) years. Mean medicated preoperative IOP was 16.9 (3.2) mmHg using a mean of 2.1 (0.9) medications, unmedicated baseline IOP (after washout) was 23.2 (2.3) mmHg, and mean IOP at every postoperative study visit was significantly lower (p<0.0002). Mean IOP from month 1 through the first postoperative year ranged from 14.7-16.2 mmHg, representing a reduction of 7.0-8.5 mmHg (30.7-36.5%). At month 12, 80% of all eyes (28/35) and 77.8% of medication-free eyes (14/18) had IOP reduction ≥20% from unmedicated baseline, and 51.4% of eyes (18/35) were medication-free. Mean medication use was significantly reduced (by 59.9-74.6%, p<0.0001) at every postoperative study visit. The only adverse event occurring in >1 eye was high IOP (n=4) which was responsive to topical medical therapy; no adverse events were attributed to the transluminal dilation procedure. Transluminal dilation of the canal of Schlemm using the STREAMLINE Surgical System combined with phacoemulsification safely and effectively reduced both IOP and dependence on IOP-lowering medications in a Hispanic population diagnosed with POAG and should be considered at the time of phacoemulsification in Hispanic patients who have a need for IOP reduction, medication reduction, or both.

To report the 12-month clinical outcomes in eyes with mild to moderate open-angle glaucoma (OAG) in Hispanic adults undergoing STREAMLINE Surgical System (STREAMLINE) canaloplasty combined with phacoemulsification. This was a prospective, multi-center, interventional clinical trial involving 45 eyes of 45 Hispanic adult patients receiving topical medical therapy for mild to moderate OAG and undergoing phacoemulsification surgery for visually significant cataracts at three sites. All eyes underwent a Screening visit, followed by medication washout and a subsequent Baseline visit to determine eligibility for STREAMLINE canaloplasty. The primary outcome was the proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20% from Baseline at Month 12. Secondary outcomes included mean change in IOP from post-washout Baseline, mean change in IOP-lowering medications compared to pre-washout Screening, and adverse events (AEs). 43 eyes met the eligibility criteria for analysis and 40 eyes completed the 12-month visit. The mean (standard deviation) age was 68.7 (8.6 years), 76.7% were female, and 72.1% of the eyes were classified as having mild OAG. The mean number of IOP-lowering medications at Screening was 1.95 (0.82). After washout, the Baseline mean IOP was 23.0 (1.8) mmHg. At Month 12, 28/40 eyes (70.0%) remained medication-free, of which 27 (96.4%) had an IOP reduction of ≥20% from Baseline. The mean IOP at Month 12 was 15.3 (2.8) mmHg, a reduction of 7.8 (3.0) mmHg from Baseline (p<0.001). The mean medication use at Month 12 was 0.63 (1.19) per eye, representing a mean reduction of 1.38 (1.03) medications from Screening (p<0.001). Device- or procedure-related ocular AEs were mostly mild in severity and self-limited. STREAMLINE canaloplasty in combination with phacoemulsification provides clinically and statistically significant reduction in IOP and IOP-lowering medications in eyes with mild to moderate OAG in Hispanic adults.

Purpose. To examine the surgical outcomes and graft conditions in patients receiving micropulse transscleral cyclophotocoagulation (MP-TSCPC) to treat post-keratoplasty ocular hypertension. Methods. This retrospective observational study included 30 eyes of 28 consecutive glaucoma patients with a history of penetrating keratoplasty (PKP) or Descemet’s stripping automated endothelial keratoplasty (DSAEK) who underwent MP-TSCPC at the University of California, San Francisco from 09/2015 to 08/2018. Using the Wilcoxon signed-rank test, we compared preoperative and postoperative intraocular pressure (IOP), number of glaucoma medications, visual acuity, and central corneal thickness at 1, 3, 6, and 12 months. Postoperative complications, additional surgeries, and graft failures were also recorded at these follow-up times. Linear regression model was used to study whether PKP vs. DSAEK affects the effectiveness of MP-TSCPC. Results. Thirty eyes from 28 patients were followed for 12 months. IOP was significantly decreased from preop at all follow-up points (P<0.001). There was no significant change in the number of glaucoma drops, visual acuity, or CCT. At 12 months, 21 of the 30 eyes met the definition of success, and only one underwent repeat PKP due to graft rejection. The type of corneal transplant was not a significant factor for IOP reduction at the last follow-up. Conclusions. MP-TSCPC achieved desirable IOP control and success rates for postkeratoplasty patients while resulting in minimal complications and graft failure. It appears to be a safe and effective procedure in patients who received corneal transplant with one-year follow-up.

Glaucoma is an important cause of irreversible blindness that represents a significant economic burden; most direct costs of glaucoma are drug-related. We calculated the annual cost of some of the most commonly prescribed glaucoma medications in Mexico, according to their average wholesale price (AWP) and dose regimen. Annual costs ranged from USD4.97 for Imot 15 ml (timolol 0.5 %; Laboratorios Sophia) to USD675.39 for Alphagan 5 ml (brimonidine 0.2 %; Allergan, Inc.). β-Blockers were the least expensive glaucoma medications (range USD20.44–55.44). Alphagan 5 ml was 250 % more expensive than other selective α 2 -agonists. Of the carbonic anhydrase inhibitors, dorzolamide 2 % was less expensive than brinzolamide 1 % (USD326.91 vs. USD418.96). The annual cost for prostaglandin analogs ranged from USD235.58 for bimatoprost 0.03 % to USD337.78 for latanoprost 0.005 %. Some fixed combinations were less expensive than separate combinations. The average annual cost for all treatments increased by 27.87 ± 10.09 % between 2009 and 2012. Annual glaucoma therapy cost seems to be lower in Mexico than in other countries, due to a lower AWP, especially for some medications made by Mexican laboratories.