Glaukos (United States)

The travoprost intracameral implant and cataract surgery both lower intraocular pressure (IOP). We evaluated the safety and IOP-lowering effect at 3 months following administration of travoprost intracameral implant in combination with cataract surgery. Prospective, 12-month, open-label, single-arm trial. We enrolled patients with age-related cataracts and open-angle glaucoma or ocular hypertension in the same eye. At baseline, patients were required to have an unmedicated mean diurnal IOP (average of 8:00 am, 10:00 am, and 4:00 pm IOPs) of 24 mmHg or greater, and an IOP of 36 mmHg or less at each of these three timepoints. On the day of the combined procedure (day 1), patients who had uncomplicated phacoemulsification cataract surgery received a travoprost intracameral implant. Follow-up evaluations occurred on day 2-3, week 2, week 6, and month 3 visits. Sixty patients had uncomplicated cataract surgery and received a travoprost intracameral implant. There were no serious adverse events. Study eye adverse events were reported in 8.3% of patients. The most frequently reported adverse event was dry eye (6.7%). At month 3, the mean diurnal IOP change from baseline was -10.6 mmHg (95% confidence interval: -11.2, -9.9; p < 0.0001) from an unmedicated baseline mean diurnal IOP of 25.2 mmHg. In addition, at month 3, 97% of eyes had a 20% or greater mean diurnal IOP reduction from baseline, and 91.0% of eyes had a mean diurnal IOP of 18 mmHg or less. Administration of a travoprost intracameral implant combined with routine cataract surgery was safe. The sizable -10.6 mmHg IOP change from baseline at month 3 was both statistically significant and clinically relevant. NCT06061718, Travoprost Intraocular Implant in Conjunction with Cataract Surgery, https://clinicaltrials.gov/study/NCT06061718.

To compare postenhancement visual acuity between patients who underwent postcataract laser in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK). A private, tertiary referral practice in Sioux Falls, South Dakota. 3-year, retrospective chart review. Patients who underwent postcataract extraction excimer laser enhancement surgery targeted for emmetropia (±0.50 diopter). Postenhancement uncorrected distance visual acuity (UDVA) and manifest refraction spherical equivalent (MRSE) was recorded for all available follow-ups and compared for both groups. 822 postcataract enhanced eyes (491 LASIK; 331 PRK). For patients with at least 6-month follow-up, mean UDVA was 0.05 ± 0.13 logMAR in LASIK-enhanced patients and 0.15 ± 0.20 in PRK-enhanced patients ( P < .001). Mean absolute value MRSE was 0.22 ± 0.36 and 0.48 ± 0.62 for LASIK-enhanced and PRK-enhanced patients at or beyond 6 months, respectively ( P < .001). 330 (67%) LASIK-enhanced patients achieved 20/20 or better postenhancement UDVA, compared with 142 (43%) PRK-enhanced patients ( P < .001). Controlling for pre-enhancement UDVA, LASIK-enhanced patients showed significantly better postenhancement UDVA than PRK-enhanced patients, except in those with pre-enhancement vision of 20/20 or better, or those worse than 20/50. LASIK-enhanced virgin corneas had mean postenhancement of 0.05 ± 0.14 UDVA compared with 0.13 ± 0.19 UDVA in PRK-enhanced virgin cornea patients ( P < .001). LASIK provides better and more predictable outcomes in UDVA than PRK in postcataract enhancement patients, even when controlling for pre-enhancement visual acuity and prior ocular procedures.

ObjectiveTo investigate the cost-effectiveness of implementing iStent inject trabecular bypass stent (TBS) in conjunction with cataract surgery (Cat Sx) in patients with mild-to-moderate glaucoma from a societal perspective in France. The secondary objective was to explore the economic impact of iStent inject TBS in patients who comply to different degrees with their anti-glaucoma medications.MethodsA previously published Markov model was adapted to estimate the cost-effectiveness of treatment with iStent inject TBS + Cat Sx versus Cat Sx alone over a lifetime time horizon in patients with mild-to-moderate open-angle glaucoma in France. Progression was modeled by health states reflecting increasing stages of vision loss. Disease progression was obtained from the two-year randomized clinical trial assessing safety and effectiveness of both interventions. French specific health-state utilities and costs were obtained through a targeted literature review. Model structure and inputs were validated by French ophthalmologists. Outcomes were expressed as incremental cost per quality-adjusted life-year (QALY) gained. The robustness of results was tested through sensitivity analyses.ResultsiStent inject TBS + Cat Sx reduced the number of medications needed and risk of blindness. Incremental cost and QALYs were €75 and 0.065 leading to an incremental cost-effectiveness ratio (ICER) of €1,154/QALY gained. ICER ranged from dominating for non-persistent patients to €31,127 patients fully persistent with their medication regime. Results from one-way sensitivity analysis had a maximum ICER of €29,000 when varying input parameters. iStent inject TBS + Cat Sx had an 86% chance of being cost-effective at a willingness-to-pay threshold of €30,000 per QALY gained.ConclusionResults demonstrate that iStent inject TBS + Cat Sx is a cost-effective intervention for intraocular pressure reduction when compared to Cat Sx alone in France.

IntroductionThis study evaluates long-term outcomes of two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin in eyes with refractory open angle glaucoma (OAG).MethodsProspective ongoing 5-year study of 80 eligible subjects (70 with 4-year follow-up) with OAG and IOP ≥ 18 mmHg after prior trabeculectomy and while taking 1–3 glaucoma medications. Subjects received two iStent® trabecular micro-bypass stents, one iStent Supra® suprachoroidal stent, and postoperative travoprost. Postoperative IOP was measured with medication and annually following medication washouts. Performance was measured by the proportion of eyes with ≥ 20% IOP reduction on one medication (the protocol-specified prostaglandin) versus preoperative medicated IOP (primary outcome); and the proportion of eyes with postoperative IOP ≤ 15 and ≤ 18 mmHg on one medication (secondary outcome). Additional clinical and safety data included medications, visual field, pachymetry, gonioscopy, adverse events, visual acuity, and slit-lamp and fundus examinations.ResultsPreoperatively, mean medicated IOP was 22.0 ± 3.1 mmHg on 1.2 ± 0.4 medications, and mean unmedicated IOP was 26.4 ± 2.4 mmHg. Postoperatively, among eyes without later cataract surgery, mean medicated IOP at all visits through 48 months was ≤ 13.7 mmHg (≥ 37% reduction), and annual unmedicated IOP was ≤ 18.4 mmHg (reductions of ≥ 30% vs. preoperative unmedicated IOP and ≥ 16% vs. preoperative medicated IOP). At all postoperative visits among eyes without additional surgery or medication, ≥ 91% of eyes had ≥ 20% IOP reduction on one medication versus preoperative medicated IOP. At month 48, 97 and 98% of eyes achieved IOP ≤ 15 and ≤ 18 mmHg, respectively, on one medication. Six eyes required additional medication, no eyes required additional glaucoma surgery, and safety measurements were favorable throughout follow-up.ConclusionIOP control was achieved safely with two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin. This microinvasive, ab interno approach introduces a possible new treatment option for refractory disease.Trial RegistrationNCT01456390.FundingGlaukos Corporation.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0666-4) contains supplementary material, which is available to authorized users.

IntroductionThe study objective was to evaluate the intraocular pressure (IOP) and medication-lowering effect of 2 second-generation trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) on one preoperative medication.MethodsFifty-seven qualified phakic eyes with OAG on 1 medication, preoperative medicated IOP of 18–30 mmHg, and preoperative unmedicated (post-washout) IOP of 22–38 mmHg underwent implantation of 2 second-generation trabecular micro-bypass stents in a standalone procedure. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit lamp examinations, visual field, cup to disc ratio, pachymetry, and complications and interventions. Subjects have been followed for 18 months, and follow-up is ongoing.ResultsAt Month 12 postoperative, 100% of eyes had achieved an IOP reduction ≥20% (100% had IOP ≤18 mmHg and 67% had IOP ≤15 mmHg) without medication versus preoperative unmedicated IOP, and 75% had IOP reduction ≥20% without medication versus preoperative medicated IOP. The Month 12 mean unmedicated IOP had decreased by 42%, to 14.2 ± 1.9 mmHg vs 24.4 ± 1.3 mmHg preoperatively, and this reduction was maintained through 18 months (14.4 ± 2.1 mmHg). A high safety profile was observed.ConclusionIn this prospective, open-label, single-arm study, the standalone implantation of two second-generation trabecular micro-bypass stents in OAG patients on 1 preoperative medication resulted in IOP reduction to ≤15 mmHg and elimination of medication through 18 months, with favorable safety.Trial RegistrationClinicalTrials.gov identifier, NCT02868190.FundingGlaukos Corporation, San Clemente, CA.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0420-8) contains supplementary material, which is available to authorized users.

Although conventional implantable cardioverter-defibrillators (ICDs) have proved effective in the prevention of sudden cardiac death (SCD), they still appear to be limited by non-trivial acute and long-term complications. The recent advent of an entirely subcutaneous ICD (S-ICD) represents a further step in the evolution of defibrillation technology towards a less-invasive approach. This review highlights some historical and current issues concerning the S-ICD that may offer a viable therapeutic option in selected patients at high risk of SCD and in whom pacing is not required. After the CE Mark and US Food and Drug Administration (FDA) approvals, the S-ICD is being implanted worldwide with growing clinical data regarding its safety and efficacy (the EFFORTLESS Registry). The recently developed new generation of S-ICD (EMBLEM, Boston Scientific) demonstrates favourable features including a smaller device, longer longevity and remote-monitoring compatibility. Further innovations in the S-ICD system and potential integration with leadless pacing may play an important role in defibrillation therapy and prevention of SCD in the near future.