Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial.

BACKGROUND: In an ageing population, efficiency improvements are required to assure future accessibility of cataract care. We aim to address remaining knowledge gaps by evaluating the safety, effectiveness, and cost-effectiveness of immediate sequential bilateral cataract surgery (ISBCS) versus delayed sequential bilateral cataract surgery (DSBCS). We hypothesised that ISBCS is non-inferior to DSBCS, regarding safety and effectiveness, and being superior in cost-effectiveness. METHODS: We did a multicentre, non-inferiority, randomised controlled trial, which included participants from ten Dutch hospitals. Eligible participants were 18 years or older, underwent expected uncomplicated surgery, and had no increased risk of endophthalmitis or refractive surprise. Participants were randomly assigned (1:1) to either the ISBCS (intervention) group or DSBCS (conventional procedure) group, using a web-based system stratified by centre and axial length. Participants and outcome assessors were not masked to the treatment groups because of the nature of the intervention. The primary outcome was the proportion of second eyes with a target refractive outcome of 1·0 dioptre (D) or less 4 weeks postoperatively, with a non-inferiority margin of -5% for ISBCS versus DSBCS. For the trial-based economic evaluation, the primary endpoint was the incremental societal costs per quality-adjusted life-year. All analyses were done by a modified intention-to-treat principle. Costs were calculated by multiplying volumes of resource use with unit cost prices and converted to 2020 Euros (€) and US$. This study was registered with ClinicalTrials.gov, number NCT03400124, and is now closed for recruitment. FINDINGS: Between Sept 4, 2018, and July 10, 2020, a total of 865 patients were randomly assigned to either the ISBCS group (427 [49%] patients; 854 eyes) or DSBCS group (438 [51%] patients; 876 eyes). In the modified intention-to-treat analysis, the proportion of second eyes with a target refraction of 1·0 D or less was 97% (404 of 417 patients) in the ISBCS group versus 98% (407 of 417) in the DSBCS group. The percentage difference was -1% (90% CI -3 to 1; p=0·526), thereby establishing non-inferiority for ISBCS compared with DSBCS. Endophthalmitis was not observed or reported in either group. Adverse events were comparable between groups, with only a significant difference in disturbing anisometropia (p=0·0001). Societal costs were €403 (US$507) lower with ISBCS than with DSBCS. The cost-effectiveness probability of ISBCS versus DSBCS was 100% across the willingness-to-pay range of €2500-80 000 (US$3145-100 629) per quality-adjusted life-year. INTERPRETATION: Our results showed non-inferiority of ISBCS versus DSBCS regarding effectiveness outcomes, comparable safety, and superior cost-effectiveness of ISBCS. National cost savings could amount to €27·4 million (US$34·5 million) annually, advocating for ISBCS if strict inclusion criteria are applied. FUNDING: Research grant from The Netherlands Organization for Health Research and Development (ZonMw) and Dutch Ophthalmological Society.

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.

Visual Complaints and Eye Problems in Orchestral Musicians.

OBJECTIVE: To study visual complaints and eye diseases among professional and amateur orchestral musicians in the Netherlands. METHODS: In this observational study, members from professional and amateur symphony or wind orchestras were asked to complete a questionnaire collecting demographic data, musical, medical, and family history, and data on present visual complaints and/or eye diseases. Questions about playing in the orchestra were also asked. RESULTS: Data from 70 professionals and 48 amateurs showed that most musicians needed glasses or contact lenses for playing in the orchestra (61% of the professionals, 63% of the amateurs). A majority (66% of professionals, 71% of amateurs) had visited an ophthalmologist at least once during their lifetime, and 10% of the professionals and 23% of the amateurs were currently under treatment of an ophthalmologist. Visual complaints while playing in the orchestra were quite common and included poor lighting conditions, problems with reading small notes, blurred vision, tired eyes, and itching or burning eyes. Professional musicians especially reported adverse effects of eye complaints encountered in the orchestra for daily life; 35% got tired earlier and 33% felt that they could not adequately perform their tasks in the orchestra. CONCLUSION: The results show that visual complaints and eye problems probably are quite common among orchestral musicians and therefore warrant further interest and research.

Evidence-Based Consensus Guidelines Series for MicroPulse Transscleral Laser Therapy - Surgical Technique, Post-Operative Care, Expected Outcomes and Retreatment/Enhancements.

Purpose: To provide expert consensus and evidence-based current guidelines on treatment technique, postoperative care, expected outcomes and retreatment for MicroPulse Transscleral Laser Treatment (TLT). Methods: A comprehensive search of PubMed led to the identification and analysis of 61 studies on MicroPulse TLT. To provide guidance in areas where there was not enough available literature, a three-round Delphi method was conducted involving 10 international experts in MicroPulse TLT. Results: The response rate was 70% in the first round, 70% in the second round, and 80% in the third round of the Delphi method. Once all responses were aggregated, a live meeting was held with 90% attendance, and consensus was achieved on each of the findings detailed in this manuscript. Conclusion: Used within appropriate treatment parameters, with proper technique and patient selection, MicroPulse TLT is a safe and effective treatment for many types and severities of glaucoma. MicroPulse TLT represents a useful addition to the glaucoma armamentarium.

Evidence-Based Consensus Guidelines Series for MicroPulse Transscleral Laser Therapy: Dosimetry and Patient Selection.

Purpose: To provide consensus-based current guidelines on optimal dosimetry and patient selection for MicroPulse Transscleral Laser Therapy (TLT) based on a review of the literature and a Delphi method. Methods: A comprehensive search of Pub Med led to the identification and analysis of 61 studies on MicroPulse TLT that contained information on laser settings and patient selection. To determine consensus in areas where there was not enough available literature, a three-round Delphi method was conducted. Results: The response rate was 90% in the first round, 90% in the second round, and 80% in the third round of the Delphi technique. Once all responses were aggregated, a live meeting was held with 80% attendance, and consensus was achieved on each of the findings detailed in this manuscript. Conclusion: Micropulse TLT is a useful addition to the glaucoma armamentarium. When used with proper surgical technique at energy settings within the boundaries described in this manuscript, MicroPulse TLT is a safe and effective treatment for many types and stages of glaucoma. Based on current knowledge and experience, the consensus recommendation of this expert panel is that the standard MicroPulse TLT settings using the revised MicroPulse P3 Probe should be 2500 mW, 31.3% duty cycle, and 4 sweeps at a sweep velocity of 20 seconds each per hemisphere. Both hemispheres avoiding the 3 and 9 clock hours should be treated. The panel also reached consensus on patient selection for MicroPulse TLT providing guidance for the use of the procedure.

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.

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

PURPOSE: To investigate the economic impact of an intracameral mydriatics and anesthetic 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: A total of 368 patients were included, the mean costs per patient were €506 in the ICMA group (n = 122), €474 in the ocular insert group (n = 115), and €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, the mean costs in the ocular insert and topical groups were comparable (€450 vs €444). There was no statistically significant difference in the use of additional mydriatics intraoperatively (P = .521). The mean ratio of pupil size to white-to-white distance was lower in the ICMA group during all intraoperative measurements (P < .001) but similar between the topical and ocular insert groups (P range .11-.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 with topical mydriatics in costs and pupil size. Implementation of ICMA could be considered when availability of nurses or physical space for perioperative care is limited.

Micropulse Trans-scleral 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. 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.