Ab interno trabecular bypass surgery with Schlemm´s canal microstent (Hydrus) for open angle glaucoma.
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ABSTRACT:
SUBMITTER: Otarola F
PROVIDER: S-EPMC7061024 | biostudies-literature | 2020 Mar
REPOSITORIES: biostudies-literature
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Ab interno trabecular bypass surgery with Schlemm´s canal microstent (Hydrus) for open angle glaucoma.
Otarola Francisco F Virgili Gianni G Shah Anupa A Hu Kuang K Bunce Catey C Gazzard Gus G
The Cochrane database of systematic reviews 20200309
<h4>Background</h4>Glaucoma is a leading cause of irreversible blindness. A number of minimally-invasive surgical techniques have been introduced as a treatment to prevent glaucoma from progressing; ab interno trabecular bypass surgery with the Schlemm's canal Hydrus microstent is one of them.<h4>Objectives</h4>To evaluate the efficacy and safety of ab interno trabecular bypass surgery with the Hydrus microstent in treating people with open angle glaucoma (OAG).<h4>Search methods</h4>On 7 May 20 ...[more]
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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-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:ObjectiveThe aim of this study was to determine whether insertion of a trabecular bypass device (TBD) is a cost-effective intervention for the treatment of open-angle glaucoma (OAG) with mild to moderate vision loss in the Australian setting.MethodsWe performed a cost-utility analysis of TBD implantation in conjunction with cataract surgery or as a standalone procedure in patients with OAG. The model used a Monte Carlo simulation to follow individual patients through a glaucoma treatment algorithm that included TBD and compared the costs and outcomes with those of patients simulated through an algorithm without TBD (usual care). The model tracked the intraocular pressure (IOP) of individual patients and then, based on this IOP, tracked the progression of the patient's glaucoma. Utility values were assigned dependent on severity of glaucoma. The analysis took the perspective of the Australian health care system. The main outcome was incremental cost per quality-adjusted life-year (QALY) of TBD versus usual care for the treatment of OAG.ResultsIn the cataract surgery population, TBD surgery was associated with incremental healthcare costs of A$177 and 0.0726 QALYs per patient, resulting in an incremental cost per QALY gained of A$2430. In the standalone population, the overall incremental cost of TBD surgery versus usual care was A$2234. With QALYs gained of 0.1526 per patient, this equated to an incremental cost per QALY gained ratio of A$14,644.ConclusionThe incremental cost per QALY estimates for TBD were below thresholds generally accepted by Australian healthcare payers, suggesting that TBD is a cost-effective intervention for patients with primary OAG in the Australian setting.
| S-EPMC9043058 | biostudies-literature
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:We investigated in vivo changes in Schlemm's canal and the trabecular meshwork in eyes with primary open angle glaucoma (POAG). Relationships between Schlemm's canal diameter, trabecular meshwork thickness, and intraocular pressure (IOP) were examined. Forty POAG patients and 40 normal individuals underwent 80-MHz Ultrasound Biomicroscopy examinations. The Schlemm's canal and trabecular meshwork were imaged in superior, inferior, nasal and temporal regions. Normal individuals had an observable Schlemm's canal in 80.3% of sections, a meridional canal diameter of 233.0±34.5 ?m, a coronal diameter of 44.5±12.6 ?m and a trabecular meshwork thickness of 103.9±11.1 ?m, in POAG patients, Schlemm's canal was observable in 53.1% of sections, a meridional canal diameter of 195.6±31.3 ?m, a coronal diameter of 35.7±8.0 ?m, and a trabecular meshwork thickness of 88.3±13.2 ?m, which significantly differed from normal (both p <0.001). Coronal canal diameter (r = -0.623, p < 0.001) and trabecular meshwork thickness (r = -0.663, p < 0.001) were negatively correlated with IOP, but meridional canal diameter was not (r = -0.160, p = 0.156). Schlemm's canal was observable in 50.5% and 56.6% of POAG patients with normal (<21 mmHg) and elevated (>21 mmHg) IOP, respectively (? = 1.159, p = 0.282). Coronal canal diameter was significantly lower in the elevated IOP group (32.6±4.9 ?m) than in the normal IOP group (35.7±8.0 ?m, p < 0.001). This was also true of trabecular meshwork thickness (81.9±10.0 ?m vs. 97.1±12.0 ?m, p < 0.001). In conclusion, eyes with POAG had fewer sections with an observable Schlemm's canal. Canal diameter and trabecular meshwork thickness were also lower than normal in POAG patients. Schlemm's canal coronal diameter and trabecular meshwork thickness were negatively correlated with IOP.
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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