Ab-Interno Canaloplasty and Ab-Interno Canaloplasty/Trabeculotomy in Glaucoma Patients Using the OMNI Surgical System

Eyes with Primary Open Angle Glaucoma (POAG) show anatomical changes within the trabecular outflow tract that increase aqueous humor outflow resistance and thus Intraocular Pressure (IOP). In these glaucomatous eyes, approximately 50–70% of the total outflow resistance is attributed by changes in the tissue of the Trabecular Meshwork (TM) and 30–50% by changes in Schlemm’s canal and/or the collector canals. In the last decade, a number of Minimally Invasive Glaucoma Surgeries (MIGS) have been developed to target the different tissue changes particularly. For example, goniotomy, trabeculotomy, and trans-TM implants target TM resistance, whereas canaloplasty, viscodilation, and stenting procedures target Schlemm’s canal and collector channels. Therefore, a procedure targeting multiple pathways of aqueous humor outflow might be more effective in lowering IOP. In a limited number of studies to date using the OMNI Surgical System either combined with phacoemulsification or as standalone system, IOP reductions of 20–35% and medication reductions of 25–75% have been reported. In this chapter, the experience in performing canaloplasty/trabeculotomy of Schlemm’s canal and distal collector channels using the OMNI Surgical System is described

3-year safety and efficacy results of PreserFloTM Microshunt in glaucoma patients: A multicentre European cohort study

Purpose To report three-year outcomes of a multicenter cohort undergoing Preserflo Microshunt surgery (PFMS). Design Retrospective cohort study Methods Retrospective review of 100 consecutive eyes (91 patients) undergoing PFMS from four tertiary-referral glaucoma centers. Primary outcome were success rates. Secondary outcomes included: intraocular pressure (IOP), best-corrected visual acuity, medication, complications and postoperative interventions. Results 100 eyes of 91 patients were included. Qualified and complete success rates (95 % CI) were 80 % (72–87 %) and 56 % (47–65 %) for Criterion A (IOP≤21 mmHg), 75 % (67–83 %) and 55 % (46–65 %) for Criterion B (IOP≤18 mmHg), 44 % (31–50 %) and 39 % (30–49 %) for Criterion C (IOP≤15 mmHg) and 10 % (5–16 %) and 10 % (5–16 %) for Criterion D (IOP≤12 mmHg) respectively. Mean IOP decreased from 23.8 mmHg to 14.1 mmHg (reduction of 35.3 %) after 36 months with a reduction of IOP-lowering agents from 2.52 (0 – 4) to 0.69 (0 – 3). 7 eyes (7 %) needed additional glaucoma surgery. Of these, 3 eyes underwent a glaucoma drainage device and 4 eyes had a trabeculectomy.36 eyes received additional procedures after PFMS implantation. Of these, 14 eyes (14 %) underwent a surgical revision and 12 eyes (12 %) a bleb needling procedure. The complication rate was low: 1 eye developed corneal decompensation and underwent a DMEK after 24 months. 1 eye had a conjunctival erosion requiring a revision surgery. 2 eyes developed a postoperative uveitis that was treated with topical steroids and resolved without further damage. There were no hypotony-related complications. Conclusions PFMS surgery is a safe and effective procedure for reducing IOP and pressure-lowering therapy

Effectiveness and safety of VISULAS ® green selective laser trabeculoplasty: a prospective, interventional multicenter clinical investigation

Purpose To evaluate the effectiveness and safety of Selective Laser Trabeculoplasty (SLT) with the SLT mode of the VISULAS ® green laser in patients with primary open-angle glaucoma (POAG). Methods This prospective, interventional multicenter clinical investigation included patients with POAG who either needed a treatment escalation because the individual intraocular pressure (IOP) target was not met or treatment initiation and had an IOP ≥ 17 mmHg at baseline in the study eye. The study was conducted in five research centers across Germany. Approximately 100 laser applications were delivered to 360° of the trabecular meshwork. Glaucoma medications were not modified during the 3-month follow-up to allow evaluation of the sole effect of VISULAS ® green with SLT. Efficacy outcomes were postoperatively absolute and relative IOP changes at 1 and 3 months. Safety outcomes analyzed the rate of intra- and postoperative adverse events. Results Thirty-four eyes of 34 POAG patients were included. The overall mean number of preoperative glaucoma medications was 2.2 ± 1.4 in 29 treated eyes, 5 eyes were treatment naïve. Mean baseline IOP (mmHg) was 21.0 ± 2.69 and was reduced by − 3.53 ± 3.34 [95% CI − 4.61; − 2.45] and − 3.59 ± 3.41 [95% CI − 4.64; − 2.53] at the 1- and 3-month follow-up, respectively (p < 0.0001), with 48.5% of cases achieving a ≥ 20% IOP reduction at 3 months [95% CI = 30.8%; 66.5%]. The mean relative IOP reduction was − 16.4% and − 16.3% at 1 and 3 months, respectively (p < 0.0001). Potentially device- or procedure-related adverse events were mild to moderate and included 3 postoperative IOP-spikes and 6 reports regarding eye pain and discomfort. All were resolved without sequelae. Conclusions SLT performed with the VISULAS ® green laser achieved clinically significant additional IOP reductions in medically treated as well as in treatment naïve eyes with POAG and there were no relevant safety issues. The results are comparable to other reported SLT studies

Short-term safety and efficacy of Preserflo™ Microshunt in glaucoma patients: a multicentre retrospective cohort study

To evaluate 1-year success rates and safety profile of Preserflo™ Microshunt in glaucoma patients.Retrospective multicentre cohort study of 100 consecutive eyes (91 patients) from four tertiary-referral glaucoma centres. Four intraocular pressure (IOP) criteria were defined: A: IOP ≤ 21 mmHg+IOP reduction ≥20% from baseline; B: IOP ≤ 18 mmHg+IOP reduction ≥20%; C: IOP ≤ 15 mmHg+IOP reduction ≥25%; D: IOP≤12 mmHg+IOP reduction ≥30%. Success was defined as qualified or complete based on whether reached with or without medication. Primary outcome was success according to the above criteria. Secondary outcomes included: IOP, best-corrected visual acuity (BCVA), medication use, complications, postoperative interventions, and failure-associated factors.Qualified and complete success rates (95% CI) at 12 months were 74%(66-83%) and 58%(49-69%) for criterion A, 72%(63-82%) and 57%(48-68%) for B, 52%(43-63%) and 47%(38-58%) for C, 29%(21-40%) and 26%(19-36%) for D. Overall median (interquartile range (IQR)) preoperative IOP decreased from 21.5(19-28) mmHg to 13(11-16) mmHg at 12 months. BCVA was not significantly different up to 12 months (p = 0.79). Preoperative median (IQR) number of medications decreased from 3 (2-3) to 0 (0-1) at 12 months. Twelve eyes underwent needling, five surgical revision and one device removal due to corneal oedema. There were no hypotony-related complications. Non-Caucasian ethnicity was the only risk factor consistently associated with increased failure.Preserflo™ Microshunt is a viable surgical option in glaucoma patients, with reasonable short-term success rates, decreased medications use, excellent safety profile, smooth postoperative care, and rapid learning curve. Success rates for the most stringent IOP cutoffs were modest, indicating that it may not be the optimal surgery when very low target IOP is require

Clinical Outcomes after Binocular Implantation of a New Trifocal Diffractive Intraocular Lens

Purpose. To evaluate visual, refractive, and contrast sensitivity outcomes, as well as the incidence of pseudophakic photic phenomena and patient satisfaction after bilateral diffractive trifocal intraocular lens (IOL) implantation. Methods. This prospective nonrandomized study included consecutive patients undergoing cataract surgery with bilateral implantation of a diffractive trifocal IOL (AT LISA tri 839MP, Carl Zeiss Meditec). Distance, intermediate, and near visual outcomes were evaluated as well as the defocus curve and the refractive outcomes 3 months after surgery. Photopic and mesopic contrast sensitivity, patient satisfaction, and halo perception were also evaluated. Results. Seventy-six eyes of 38 patients were included; 90% of eyes showed a spherical equivalent within ±0.50 diopters 3 months after surgery. All patients had a binocular uncorrected distance visual acuity of 0.00 LogMAR or better and a binocular uncorrected intermediate visual acuity of 0.10 LogMAR or better, 3 months after surgery. Furthermore, 85% of patients achieved a binocular uncorrected near visual acuity of 0.10 LogMAR or better. Conclusions. Trifocal diffractive IOL implantation seems to provide an effective restoration of visual function for far, intermediate, and near distances, providing high levels of visual quality and patient satisfaction