Ab interno trabecular bypass surgery with iStent for open-angle glaucoma.
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SUBMITTER: Le JT
PROVIDER: S-EPMC6437719 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC7061024 | biostudies-literature
Project description:BackgroundThe short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up.MethodsThis longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events.ResultsA total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease.ConclusionsImplantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.
| S-EPMC8594216 | biostudies-literature
Project description:Background/objectivesTo describe intraocular pressure (IOP) and ocular hypotensive medication outcomes of combined phacoemulsification and ab interno trabeculectomy with the Kahook Dual Blade (KDB; New World Medical, Inc, Rancho Cucamonga, CA) in adults with cataract and open-angle glaucoma (OAG).Subjects/methodsRetrospective chart review of existing medical records. Data collected included intraocular pressure (IOP) and IOP-lowering medication use preoperatively and through up to 24 months postoperatively. Paired t-tests were utilized to compare preoperative to postoperative mean IOP and mean medications used.ResultsData from 32 eyes of 26 subjects were analyzed. Subjects were predominantly Caucasian (25/26) had mean (standard error) age of 79.3 (1.2) years, and eyes had moderate-advanced OAG (mean visual field mean deviation -8.3 [1.3] dB). Mean IOP was 19.8 (0.8) mmHg at baseline and 15.5 (0.6) mmHg (p<0.0001) after mean follow-up of 11.5 (1.0) months; IOP reductions of ≥20% were achieved in 20/32 eyes (62.5%). Mean medication use declined from 2.4 (0.2) medications per eye at baseline to 0.5 (0.2) at last follow-up (p<0.0001); 23/32 eyes (71.9%) were medication-free at last follow-up. No vision-threatening complications were observed.ConclusionsCombined phacoemulsification and ab interno trabeculectomy with the KDB safely provided mean IOP reductions of 21.7% and mean IOP medication reductions of 83% after mean follow-up of 12 months in eyes with moderate to advanced OAG. This procedure provides medication-independence in most eyes with statistically and clinically significant IOP reductions.
| S-EPMC8211240 | biostudies-literature
Project description:Recently introduced microincisional glaucoma surgeries that enhance conventional outflow offer a favorable risk profile over traditional surgeries, but can be unpredictable. Two paramount challenges are the lack of an adequate training model for angle surgeries and the absence of an intraoperative quantification of surgical success. To address both, we developed an ex vivo training system and a differential, quantitative canalography method that uses slope-adjusted fluorescence intensities of two different chromophores to avoid quenching. We assessed outflow enhancement by trabecular micro-bypass (TMB) implantation or by ab interno trabeculectomy (AIT). In this porcine model, TMB resulted in an insignificant (p?>?0.05) outflow increase of 13?±?5%, 14?±?8%, 9?±?3%, and 24?±?9% in the inferonasal, superonasal, superotemporal, and inferotemporal quadrant, respectively. AIT caused a 100?±?50% (p?=?0.002), 75?±?28% (p?=?0.002), 19?±?8%, and 40?±?21% increase in those quadrants. The direct gonioscopy and tactile feedback provided a surgical experience that was very similar to that in human patients. Despite the more narrow and discontinuous circumferential drainage elements in the pig with potential for underperformance or partial stent obstruction, unequivocal patterns of focal outflow enhancement by TMB were seen in this training model. AIT achieved extensive access to outflow pathways beyond the surgical site itself.
| S-EPMC5095709 | biostudies-other
Project description:PurposeTo examine outcomes through 36 months in phakic eyes with newly diagnosed primary open-angle glaucoma (POAG) naïve to therapy randomized to treatment with two trabecular micro-bypass stents or topical prostaglandin.MethodsSubjects with POAG naïve to therapy, with intraocular pressure (IOP) ≥21 and ≤40 mmHg, were randomized to implantation of two stents or travoprost. Additional medication was to be prescribed post-treatment for elevated IOP or glaucomatous optic nerve findings. Of 101 randomized subjects, 100 subjects were followed for 24 months and 73 subjects were followed for 36 months. Follow-up on all subjects is ongoing.ResultsIn this randomized cohort of 101 POAG subjects, 54 subjects underwent 2-stent surgery and 47 received topical travoprost. Mean pre-treatment IOP was 25.5 ± 2.5 mmHg in stent-treated eyes and 25.1 ± 4.6 mmHg in medication-treated eyes. By 3 years, mean IOP was 14.6 mmHg in stent eyes (with medication added in 6 eyes) and 15.3 mmHg in travoprost eyes (with a second medication added in 11 eyes). In the subset of eyes that did not require additional medical therapy, mean IOP was 14.5 mmHg and 15.7 mmHg in the respective groups. Ninety-one percent of stent eyes had 3-year IOP ≤18 mmHg without additional therapy (62% ≤ 15 mmHg) and 79% of travoprost eyes had 3-year IOP ≤18 mmHg (21% ≤ 15 mmHg). Safety was favorable in both groups.ConclusionsIn this prospective, randomized comparison of subjects with newly diagnosed POAG naïve to therapy, substantial IOP reduction with a favorable low complication rate was shown through 3 years after either 2 trabecular stents implanted as the sole procedure or topical travoprost therapy. These data suggest 2-stent implantation may be a viable initial treatment option comparable to topical prostaglandin in newly diagnosed POAG patients.Trial registrationClinicalTrials.gov identifier, NCT01443988.FundingGlaukos Corporation, Laguna Hills, CA.
| S-EPMC5125126 | biostudies-literature
Project description:ObjectivesTo compare the efficacy and safety of two Schlemm's canal-based microinvasive glaucoma surgery (MIGS) devices, the Hydrus Microstent and the iStent Trabecular Bypass combined with phacoemulsification for treatment of open-angle glaucoma.DesignSystematic review and network meta-analysis.MethodsLiterature searches were conducted on PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov to identify randomised controlled trials (RCTs) assessing the Hydrus or the iStent implantation combined with phacoemulsification for treatment of open-angle glaucoma until September 2020. Risk of bias was assessed using a six-item modified Jadad scale. Effects were estimated using the intraocular pressure (IOP) reduction (IOPR), the percentage of IOPR and the proportion of medication-free patients at follow-up end. Safety was estimated using the proportions of adverse events. The network meta-analysis was conducted within a Bayesian framework using the Markov Chain Monte Carlo method in ADDIS software.ResultsSix prospective RCTs comprising 1397 patients were identified. Regarding the absolute value and the percentage of IOPR, the Hydrus and 2-iStent implantation combined with phacoemulsification were significantly more effective than phacoemulsification alone. Rank probability analysis revealed the Hydrus might be the best choice to lower IOP. There was no significant difference in the proportion of medication-free patients among groups. The Hydrus and 2-iStent implantation had a higher probability to achieve the medication-free status versus the 1-iStent implantation and phacoemulsification alone. Overall safety profiles were good for each device with the focal peripheral anterior synechiae more frequently reported in Hydrus eyes.ConclusionsThe Hydrus implantation may have a slight advantage over the 1-iStent or 2-iStent implantation in combination with phacoemulsification to treat open-angle glaucoma. Our findings might be of some uncertainty due to the limited included data. Further studies are needed to investigate whether our findings are robust, including high-quality RCTs to directly compare these MIGS devices.
| S-EPMC9204447 | biostudies-literature
Project description:IntroductionMicro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain.MethodsIn this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit.ResultsSixty-six percent of subjects achieved IOP ≤18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP ≤ 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects.ConclusionIn this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.
| S-EPMC3930835 | biostudies-literature
Project description:PurposeThe aim of this investigation was to evaluate the impact of iStent (the first-generation trabecular bypass) implantation with phacoemulsification on the intraocular pressure (IOP) and glaucoma medication in subjects with mild to moderate open-angle glaucoma (OAG) and cataract in a Polish Caucasian population.Patients and methodsThis prospective case series covered 78 eyes of (57 Polish Caucasian patients) that had undergone iStent implantation in conjunction with cataract surgery. Patients were surveyed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12, and 24. Pre- and postoperative outcome measurements included visual acuity, IOP, and medication burden. Intraoperative and postoperative complications were noted for the safety profile. For effective treatment, an IOP reduction ≥20% was assumed, regardless of the use of IOP-lowering drops. Complete surgical success was defined as an IOP ≤ 15 mmHg, medications free, and a qualified surgical success as IOP ≤ 15 mmHg with or without medications.ResultsPost-operatively at two years, mean IOP reduced from 18.5 mmHg to 16.1 mmHg. The mean medication burden dropped from 1.8 to 0.4 at the end of follow-up. Preoperatively, 2 (2.6%) eyes were medication free, but by postoperative month 24, 53 (68%) eyes were medication-free (p < 0.05). Effective treatment was achieved in 50 cases (64%) at the end of follow-up period. Kaplan-Meier cumulative incidence of qualified success was 51.9% after 24 months, CI95 [41.9%; 64.4%], while cumulative incidence of complete success after 2 years of observation was 35.1%, CI95 [25.9%; 47.5%].ConclusionThe iStent device combined with a cataract surgery served to decrease, significantly and positively, both IOP and medication use in the 24-months follow-up in patients with coexistent OAG and cataract in Polish patients.
| S-EPMC7882442 | biostudies-literature
Project description:PURPOSE:To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG) not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively. MATERIALS AND METHODS:Subjects with medicated intraocular pressure (IOP) 18-30 mmHg and postmedication-washout baseline IOP 22-38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg. RESULTS:A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ?20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ?18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ?15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001) with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96-2.73) for three-stent vs two-stent groups and 1.73 mmHg (95% confidence interval 0.83-2.64) for two-stent vs one-stent groups. Adverse events through 18 months were limited to cataract progression with best-corrected visual acuity loss and subsequent cataract surgery. CONCLUSION:In this series, implantation of each additional stent resulted in significantly greater IOP reduction with reduced medication use. Titratability of stents as a sole procedure was shown to be effective and safe, with sustained effect through 18 months postoperatively in OAG not controlled with medication.
| S-EPMC4686332 | biostudies-literature
Project description:BackgroundGlaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study was to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective.MethodsSimulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses.ResultsResults of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8368.51 vs. €7134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The cost-effectiveness accessibility curve (CEAC) showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained.ConclusionsThe results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective.
| S-EPMC8369731 | biostudies-literature