Cost analysis of mydriasis strategies in cataract surgery care in the Netherlands

PURPOSE: To investigate the economic impact of an intracameral mydriatics and anesthesic agent (ICMA), topical mydriatics, and a mydriatic ocular insert in cataract patients. SETTING: One public hospital in the Netherlands. DESIGN: Prospective cohort study. METHODS: Resource use data were collected from a healthcare and societal perspective on the day of surgery. Other outcome parameters included pupil size, surgeon satisfaction, postoperative pain, and Catquest-9SF scores. RESULTS: Mean costs per patient were &OV0556; 506 in the ICMA group (n=122), &OV0556; 474 in the ocular insert group (n=115), and &OV0556; 451 in the topical group (n=131). The acquisition cost of ICMA was highest and resulted in longer surgical time. After correction for an imbalance in the distribution of fast and slow surgeons, mean costs in the ocular insert and topical groups were comparable (&OV0556; 450 versus &OV0556; 444). There was no difference in the use of additional mydriatics intraoperatively (P=0.521).The mean ratio of pupil size to white-to-white distance was lower in the ICMA group during all intraoperative measurements (P<0.001), but similar between the topical and ocular insert groups (P range 0.11-0.82). CONCLUSIONS: In the investigated setting in the Netherlands, ICMA was the most costly strategy. In addition, pupil size was lowest in the ICMA group, but did not result in more additional mydriasis measures intraoperatively. The ocular insert was comparable to topical mydriatics in regard to costs and pupil size. Implementation of ICMA could be considered when availability of nurses or physical space for perioperative care is limited

Micropulse Transscleral Cyclophotocoagulation in Patients with Glaucoma: 1- and 2-year Treatment Outcomes

Précis: Micropulse trans-scleral cyclophotocoagulation (TSCPC) is an effective and safe IOP-lowering treatment for patients with primary or secondary glaucoma. Purpose: To investigate the 1-year and 2-year effect on intraocular pressure (IOP) and safety profile of micropulse TSCPC in patients with glaucoma. Methods: Patients with glaucoma underwent a standardized micropulse TSCPC (MicroPulse P3 probe, Iridex cyclo G6 laser system, Mountain View, CA) at the University Eye Clinic Maastricht from November 2016 to May 2018. Patients with at least 12 months of follow-up were included. Results: A total of 141 eyes of 136 patients were included. The mean age was 67.2±14.5 years, and 56.6% of patients were male individuals. The glaucoma subtypes treated were primary glaucoma (n=99) and secondary glaucoma (n=42). Prior glaucoma surgery was performed in 59 of 141 eyes (41.8%). The mean preoperative IOP was 23.5±9.4 mm Hg. The mean postoperative IOP dropped to 16.8±8.4, 17.0±7.8, and 16.8±9.2 mm Hg, after 12, 18, and 24 months, respectively. The mean number of IOP-lowering medications used preoperatively was 3.3±1.4. The mean number of medications used at 12, 18, and 24 months was respectively 2.6±1.5, 2.5±1.4, and 2.2±1.5. Postoperative complications included cystic macular edema (n=2), hypotony maculopathy (n=1), fibrinous/uveitic reaction (n=1), and rejection of corneal graft (n=1), all reversible after treatment. One patient developed persisting hypotony in the late postoperative period. Conclusions: Micropulse TSCPC is a safe and effective treatment for lowering both IOP and the number of IOP-lowering medications. Micropulse TSCPC can also be considered as a good alternative treatment option for patients after failed incisional glaucoma surgery or patients who are at high risk for incisional surgery

Intraocular pressure fluctuations and 24-hour continuous monitoring for glaucoma risk in wind instrument players

Purpose: The purpose of this study is to investigate the influence of playing a wind instrument on intraocular pressure (IOP) and to monitor 24-hour (IOP) fluctuations in wind musicians of symphony and wind orchestras to compare IOP levels during normal daily activities with IOP levels during playing.\u3cbr/\u3e\u3cbr/\u3eMethods: Professional and amateur musicians of symphony and wind orchestras were invited to participate. A total of 42 participants, 9 with glaucoma, underwent a routine ophthalmologic examination. IOP measurements were taken before and immediately after 20 minutes of playing wind instruments. In addition, 6 participants underwent 24-hour IOP monitoring with the Triggerfish (Sensimed AG, Switzerland) sensing contact lens, during which they kept an activity logbook.\u3cbr/\u3e\u3cbr/\u3eResults: Eleven professionals and 31 amateur musicians participated in the study. A total of 7 eyes of 6 patients underwent additional 24-hour IOP monitoring. Mean IOP before playing was 13.6±2.6 mm Hg, IOP change after playing was +1.5±2.2 mm Hg with a significant difference between professionals (2.5±1.5 mm Hg) and amateurs (1.1±2.3 mm Hg). There were no significant differences in IOP change between subjects with or without glaucoma. During 24-hour IOP monitoring there were slight increases in IOP while playing an instrument, but also during other activities and overnight. These latter IOP levels were similar or even higher than the IOP rise caused by playing a wind instrument.\u3cbr/\u3e\u3cbr/\u3eConclusions: IOP often rises after playing wind instruments, but similar or even higher IOP levels seem to occur during common other daily activities or at night. These peaks may be relevant for glaucomatous field progression and treatment of glaucoma patients.\u3cbr/\u3

Cost analysis of mydriasis strategies in cataract surgery care in the Netherlands

PURPOSE: To investigate the economic impact of an intracameral mydriatics and anesthesic agent (ICMA), topical mydriatics, and a mydriatic ocular insert in cataract patients. SETTING: One public hospital in the Netherlands. DESIGN: Prospective cohort study. METHODS: Resource use data were collected from a healthcare and societal perspective on the day of surgery. Other outcome parameters included pupil size, surgeon satisfaction, postoperative pain, and Catquest-9SF scores. RESULTS: Mean costs per patient were &OV0556; 506 in the ICMA group (n=122), &OV0556; 474 in the ocular insert group (n=115), and &OV0556; 451 in the topical group (n=131). The acquisition cost of ICMA was highest and resulted in longer surgical time. After correction for an imbalance in the distribution of fast and slow surgeons, mean costs in the ocular insert and topical groups were comparable (&OV0556; 450 versus &OV0556; 444). There was no difference in the use of additional mydriatics intraoperatively (P=0.521).The mean ratio of pupil size to white-to-white distance was lower in the ICMA group during all intraoperative measurements (P<0.001), but similar between the topical and ocular insert groups (P range 0.11-0.82). CONCLUSIONS: In the investigated setting in the Netherlands, ICMA was the most costly strategy. In addition, pupil size was lowest in the ICMA group, but did not result in more additional mydriasis measures intraoperatively. The ocular insert was comparable to topical mydriatics in regard to costs and pupil size. Implementation of ICMA could be considered when availability of nurses or physical space for perioperative care is limited

XEN® Gel Stent compared to PRESERFLO™ MicroShunt implantation for primary open-angle glaucoma:two-year results

Purpose To evaluate the long-term efficacy and safety of two minimally invasive glaucoma surgery implants with a subconjunctival drainage approach: the XEN45 Gel Stent® (Xen) implant and the PRESERFLO™ MicroShunt (MicroShunt). Methods Retrospective comparative case series of primary open-angle glaucoma (POAG) patients with at least 6 months of follow-up after a MicroShunt or Xen implantation augmented with mitomycin C. Results Forty-one eyes of 31 patients underwent Xen implantation, and 41 eyes of 33 patients, MicroShunt implantation. Baseline characteristics were similar, except for more combined surgeries with phacoemulsification in the Xen group (37% vs. 2%). Mean baseline IOP ± standard deviation dropped from 19.2 ± 4.4 to 13.8 ± 3.8 mmHg (n = 26) in the Xen group and from 20.1 ± 5.0 to 12.1 ± 3.5 (n = 14) in the MicroShunt group at 24 months of follow-up (p = 0.19, t-test). The number of IOP-lowering medications dropped from 2.5 ± 1.4 to 0.9 ± 1.2 in the Xen group and from 2.3 ± 1.5 to 0.7 ± 1.1 in the MicroShunt group. The probability of qualified success was 73% and 79% at 24 months of follow-up for the Xen and MicroShunt groups, respectively. Postoperative complications were usually mild and self-limiting. The number of bleb needling and secondary glaucoma surgery procedures was similar in both groups; however, in the Xen group more additional MicroPulse® transscleral cyclophotocoagulation procedures were performed. Conclusion Xen Gel Stent and PreserFlo MicroShunt implantations achieved comparable results in POAG eyes in terms of IOP-lowering and surgical success, with a similar high safety profile

Intraocular Pressure Fluctuations and 24-Hour Continuous Monitoring for Glaucoma Risk in Wind Instrument Players

Purpose: The purpose of this study is to investigate the influence of playing a wind instrument on intraocular pressure (IOP) and to monitor 24-hour (IOP) fluctuations in wind musicians of symphony and wind orchestras to compare IOP levels during normal daily activities with IOP levels during playing. Methods: Professional and amateur musicians of symphony and wind orchestras were invited to participate. A total of 42 participants, 9 with glaucoma, underwent a routine ophthalmologic examination. IOP measurements were taken before and immediately after 20 minutes of playing wind instruments. In addition, 6 participants underwent 24-hour IOP monitoring with the Triggerfish (Sensimed AG, Switzerland) sensing contact lens, during which they kept an activity logbook. Results: Eleven professionals and 31 amateur musicians participated in the study. A total of 7 eyes of 6 patients underwent additional 24-hour IOP monitoring. Mean IOP before playing was 13.6±2.6 mm Hg, IOP change after playing was +1.5±2.2 mm Hg with a significant difference between professionals (2.5±1.5 mm Hg) and amateurs (1.1±2.3 mm Hg). There were no significant differences in IOP change between subjects with or without glaucoma. During 24-hour IOP monitoring there were slight increases in IOP while playing an instrument, but also during other activities and overnight. These latter IOP levels were similar or even higher than the IOP rise caused by playing a wind instrument. Conclusions: IOP often rises after playing wind instruments, but similar or even higher IOP levels seem to occur during common other daily activities or at night. These peaks may be relevant for glaucomatous field progression and treatment of glaucoma patients

Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial

Background: Trabeculectomy is the “gold standard” initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. Methods: A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. Discussion: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. Trial registration: ClinicalTrials.gov, Identifier: NCT03931564, Registered 30 April 2019

Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial

Abstract Background Trabeculectomy is the “gold standard” initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. Methods A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. Discussion This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. Trial registration ClinicalTrials.gov, Identifier: NCT03931564 , Registered 30 April 2019