New suture probe canaloplasty combined with suprachoroidal collagen implantation.

PURPOSE: To present the modified surgery technique of new suture probe canaloplasty with a specially prepared monofilament 4.0 polypropylene suture combined with suprachoroidal drainage (ScD) and collagen sheet implantation for non-penetrating glaucoma surgery. METHODS: Prospective study with a twelve months follow-up. A standard 4/0 polypropylene suture (ProleneTM by Ethicon; thickness: approximately 250 m) is cut and shaped with an ophthalmic knife (MANI® Crescent Knife, Mani Inc 8-3 Kiyohara Industrial Park, Utsunomiya, Tochigi 321-3231, Japan) to create a blunt end without sharp or compressed edges. This improves suture probe canaloplasty by providing a more stable and smoother probing device. Schlemm's canal is prepared using the standard technique of canaloplasty with suprachoroidal drainage. Then, instead of using the canaloplasty microcatheter or the previously published 6/0 double-helix suture, Schlemm's canal is probed with the blunt ending of the 4/0 Prolene suture. After successful 360-degree probing, a doubled 10/0 polypropylene tension suture is threaded through the tip of the 4/0 suture. The 4/0 suture is then pulled back and the 10/0 tension sutures are tied at both ends to tension Schlemm's canal. A special collagen sheet (Ologen®) is placed in suprachoroidal space, and the scleral flap is firmly sewed. RESULTS: 115 eyes were included in this prospective study. In 113 cases the Schlemm's canal could completely be probed with the suture probe and canaloplasty with ScD and collagen sheet implantation succeeded. In two cases the intervention was transformed to 360-degree suture trabeculotomy due to an intraoperative cheese-wiring. Twelve months after successful new suture probe canaloplasty with ScD and Collagen Implantation the IOP had decreased by 37.1% (from 21.6 ± 6.0 mmHg with 3.3 different IOP lowering eye drops to 13.5 ± 3.5 mmHg with 1.0 eye drops). 16 Patients did not achieve sufficient IOP levels and underwent 360-degree suture trabeculotomy during the follow-up. One patient had to be treated with further glaucoma surgery to achieve a sufficient IOP level. Complications were hyphema, postoperative IOP elevation and transient hypotony. No serious or sight-threatening complications occurred. CONCLUSION: New suture probe canaloplasty with ScD and collagen sheet implantation yields the opportunity to conduct a cost-effective canaloplasty easier and less complicated than with the previously described method with the twisted 6/0 suture. The safety profile and IOP lowering effect is comparable. In cases where complete probing fails, there is still the opportunity to switch to suture trabeculotomy over the majorly probed part of Schlemm's canal. The pressure lowering effect of the deep sclerectomy with ScD and suprachoroidal collagen sheet implant seems to have an additional impact on the sufficient pressure lowering procedure.

Recanalization of Xen45 gel stent implant occlusion using 10 - 0 nylon suture in refractory glaucoma: a case report.

BACKGROUND: Xen Gel Stent implant is a new minimally invasive surgical treatment for glaucoma that has been proven effectiveness and safety profile. However, it may also lead to some complications. Xen Gel Stent occlusion is a relatively rare complication reported less frequently and has limited treatment experience. In our case report, we proposed a novel surgical treatment using a 10 - 0 nylon suture to successfully recanalize the occluded Xen45 Gel Stent. CASE PRESENTATION: A 16-year-old female patient had bilateral juvenile glaucoma for the past 5 years. Her right eye had undergone three glaucoma surgeries but failed. At a presentation to our hospital, the right eye's intraocular pressure (IOP) was 30 mmHg despite applying four different active principles. Xen45 Gel Stent implant was chosen for treatment, but six days after implantation, the IOP rose to 40 mmHg as a result of an anterior chamber tip occlusion of the Xen45 Gel Stent. Nd: YAG laser shockwave therapy was attempted but failed. The patient eventually had to return to the operating room for a revision procedure. The Xen45 Gel Stent was recanalized from the ab externo by making an L-shaped conjunctival incision at the fornix base and threading a 10 - 0 nylon suture through it. The IOP was successfully controlled in the 11-month follow-up without medication. CONCLUSION: If postoperative occlusion arises after Xen45 Gel Stent implantation, surgery using 10 - 0 nylon suture to recanalize Xen45 Gel Stent should be considered as a relatively safe, effective that does not require removal of Xen45 Gel Stent.

Clinical outcomes of the PAUL® glaucoma implant: One-year results.

BACKGROUND: To report one-year outcomes from a single-centre cohort undergoing PAUL® Glaucoma Implant (PGI) surgery. METHODS: Retrospective review of patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from April 2021 to September 2021. RESULTS: Forty-five eyes of 41 patients were included. Qualified and complete success rates (95% CI) were 95.6% (88.9%-100%) and 73.3% (60%-86.7%) for Criterion A (IOP ≤ 21 mmHg), 84.4% (73.3%-93.3%) and 74.4% (51.1%-80.0%) for Criterion B (IOP ≤ 18 mmHg), 62.2% (48.9%-75.6%) and 46.7% (31.2%-62.2%) for Criterion C (IOP ≤ 15 mmHg) and 26.7% (13.3%-40.0%) and 22.2% (11.1%-33.3%) for Criterion D (IOP ≤ 12 mmHg), respectively. Mean IOP decreased from 26.1 mmHg (7-48 mmHg) to 12.0 mmHg (3-24 mmHg) (reduction of 48.83%) after 12 months with a reduction of IOP-lowering agents from 0.5 (0-3). One eye (2.2%) needed an injection of viscoelastic due to significant hypotony with AC shallowing, and four eyes (8.9%) developed choroidal detachments due to hypotony which resolved without further interventions after 6 weeks. Three patients (6.7%) developed tube exposure which required conjunctival revision with an additional pericardial patch graft. An intraluminal prolene stent was removed in 19 eyes (42.2%) after a mean time period of 8.4 months (2-12 m). Mean IOP before the removal was 21.9 mmHg (12-38 mmHg) and decreased to 11.3 mmHg (6-16 mmHg). CONCLUSIONS: PGI surgery is an effective procedure for reducing IOP and pressure-lowering therapy. An intraluminal prolene stent impedes hypotony in the early postoperative phase and enables further IOP lowering without additional interventions during the postoperative course.

Suprachoroidal drainage with collagen sheet implant- a novel technique for non-penetrating glaucoma surgery.

PURPOSE: Our purpose was both to introduce the new technique of suprachoroidal drainage with collagen sheet implantation as a novel technique of non-penetrating glaucoma surgery and to present first results of a prospective pilot study. METHODS: A superficial rectangular sclera flap of half-scleral thickness sized 4 × 4.5 mm is dissected anteriorly until clear cornea. Then, a second scleral flap is created underneath the first one sized 3.5x4mm and is cut down full-thickness to the choroid exposing the suprachoroidal space. The flap is then bluntly prepared until the scleral spur is reached. Sharp dissection above the sclera spur exposes Schlemm's canal, which is located directly anteriorly. Schlemm's canal is unroofed, juxtacanalicular meshwork is peeled and the deep flap is cut off at its base. An absorbable collagen sheet (Ologen®, Dahlhausen, Cologne, Germany) is placed into the suprachoroidal space at the level of the ciliary body, and the superficial sclera flap is sutured tightly to prevent leakage. RESULTS: We prospectively analyzed 65 eyes that underwent suprachoroidal drainage with collagen sheet implantation. Mean reduction of intraocular pressure after 3 months was 35.1% (from 21.0 ± 4.3 mmHg to 13.5 ± 3.4 mmHg)(p < 0.01) and after 12 months 35.6% (from 21.0 ± 4.3 mmHg to 13.5 ± 3.0  mmHg)(p < 0.01). The number of topical IOP-reducing medication decreased significantly from 3.5 ± 0.7 to 0.6 ± 0.9 and to 0.9 ± 1.1 after 3 and 12 months, respectively (p < 0.01). No serious complications occurred. CONCLUSION: Suprachoroidal drainage with collagen sheet implantation seems to be a safe and effective surgical technique for non-penetrating glaucoma surgery that yields the opportunity of a sufficient IOP reduction for eyes unsuitable for canaloplasty.

Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year.

BACKGROUND: To assess the efficacy and safety of collagen matrix implant (Ologen) in phacotrabeculectomy. DESIGN: Prospective, non-randomized, comparative study. PARTICIPANTS: Sixty-six Asian patients. METHODS: Thirty three consecutive patients underwent phacotrabeculectomy with Ologen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin C augmentation. MAIN OUTCOME MEASURES: The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes. RESULTS: The overall percentage reduction in intraocular pressure was 13% (95% confidence interval 6.7-19.2) in the Ologen group and 26% (95% confidence interval 14.8-37.9) in the mitomycin C group (P = 0.05). At 1 year after surgery (after adjusting for baseline differences), intraocular pressure decreased by 4.2 mmHg (95% confidence interval 2.8-5.6 mmHg) and 5.6 mmHg (95% confidence interval 4.2-7.0 mmHg), respectively (P = 0.16). Needling with 5-fluorouracil was required more often in the Ologen group (39% vs. 6%; P = 0.003). There was similar frequency (<10%) of adverse events in both groups, and there were no complications directly related to the Ologen implant. The blebs in the mitomycin C group had greater central area (P = 0.005), maximal area (P = 0.01) and height (P = 0.005), and were less vascular (P = 0.023) than the Ologen blebs. CONCLUSIONS: At 1 year, the overall performance of Ologen in combined phacotrabeculectomy was suboptimal compared with combined surgery with mitomycin C. Eyes in the Ologen group required more frequent bleb needling procedures.

Gonioscopy-assisted transluminal trabeculotomy: Passing the right way decoding suture.

Background: Trabeculectomy is still the most frequently performed glaucoma surgery. But being an invasive procedure, it has numerous vision-threatening complications along with bleb-related complications like cystic bleb, overhanging bleb blebitis, or endophthalmitis. The choice of therapy between medical laser and filtering surgery is now bridged by minimally invasive glaucoma surgeries (MIGS), which are conjunctiva-sparing procedures with adequate intraocular pressure (IOP)-lowering effects and good safety profiles. Among the armamentarium of MIGS procedures, gonioscopy-assisted transluminal trabeculotomy (GATT) is a frontrunner safe procedure. The procedure is a blebless and sutureless procedure in which a readily available Prolene suture is used to cleave the entire trabecular meshwork. An ab interno approach also allows direct visualization of a so-called trabecular shelf that, when present, indicates an open, cleaved collector system commonly associated with a positive postoperative outcome. Thus, it not only saves the eye from various postoperative complications of other previous penetrating procedures, but is also an effective glaucoma surgery that can be performed with very low costs, which would have big economic implications for glaucoma care in developing countries. Purpose: The purpose of this video is to illustrate transluminal novel trabeculotomy technique and video-based skill transfer to a novice surgeon. Synopsis: This video depicts detailed steps of GATT surgery in a patient with primary open angle glaucoma and in a case of silicon oil induced secondary open angle glaucoma. The authors also share their experience regarding possible intraoperative problems and solutions with some tips and tricks to make the surgery easy. Highlights: GATT can be performed with cataract surgery with minimal patient morbidity and a short recovery time with preserving healthy conjunctiva. There is no risk of post op hypotony or bleb related complications, with a short surgical learning curve. Online Video Link: https://youtu.be/gk1of38EX1g.

Polyethylene Glycol-Based Synthetic Hydrogel Sealant for Filtration Bleb Leaks: An In Vivo and Histologic Study.

Purpose: To evaluate the efficacy of polyethylene glycol (PEG)-based synthetic sealant for closing bleb leaks after glaucoma filtration surgery. Methods: Tube shunt surgery that included implantation of a 22-gauge indwelling catheter and intraoperative mitomycin C was performed in the left eyes of 11 New Zealand white rabbits. Seven days postoperatively, all filtration blebs were perforated with an 18-gauge needle to create a bleb hole. In six rabbits, the holes were covered with the sealant and irradiated with blue-green light for 60 seconds; in the five control rabbits, the holes were untreated. For 3 weeks after the tube shunt surgery, the eyes were checked for bleb leaks, and the intraocular pressure (IOP) was measured in both eyes. Finally, the operated eyes were enucleated for histologic examination. Results: The bleb leaks stopped in the eyes in which sealant was used and persisted in the other eyes. The sealant preserved the bleb function; the IOPs in these eyes were significantly (P < 0.05) lower than the right eyes that did not undergo surgery. Hematoxylin and eosin staining showed that the holes were closed and covered with conjunctival epithelial cells in the eyes in which sealant was applied; the holes were open in the control eyes. Immunohistochemical staining showed that the bleb holes in which the sealant was applied had fewer inflammatory cells. Conclusions: The PEG sealant has the potential to seal bleb leaks effectively. Translational Relevance: Application of the PEG sealant can be used as adjunct therapy for bleb leaks in glaucoma surgery.

Phacotrabeculectomy using collagen matrix implant (Ologen® ) versus mitomycin C: a prospective randomized controlled trial.

PURPOSE: To compare the efficacy and safety of collagen matrix implant (Ologen® ; OLO) with mitomycin C (MMC) in phacotrabeculectomy. METHODS: Prospective, single-centre, nonblinded, randomized controlled trial. A total of 53 eyes of 45 patients were enrolled in the study protocol with 27 eyes randomly assigned to OLO and 26 to MMC. The follow-up was 12 months. The primary outcome measure was mean change from baseline intraocular pressure (IOP) in both groups after 12 months. The secondary outcome measures were cumulative success rates at 12 months with Kaplan-Meier analysis, change in number of medications, change in best corrected visual acuity (BCVA), and bleb morphology assessed using Moorfields Bleb Grading System and anterior segment swept-source optical coherence tomography. RESULTS: The mean IOP decreased from 26.4 ± 6.1 mmHg to 13.7 ± 3.8 in the OLO group and from 23.4 ± 3.6 mmHg to 13.3 ± 2.8 in the MMC group at 1 year without significant intergroup differences. At 1 year, the overall success rates were 92.6% and 92.3% in the OLO and MMC groups, respectively. There were no significant differences in the overall success rates, BCVA, number of medications, morphology of the filtering blebs and rate of complications at the end of the follow-up. CONCLUSION: Ologen (OLO) provides similar surgical outcomes in phacotrabeculectomy compared with adjunctive MMC. It may be a new, safe and effective alternative to MMC for combined phacoemulsification and trabeculectomy surgery.

Glaucoma drainage devices / Dispositivos de drenagem para glaucoma

ABSTRACT Glaucoma drainage devices are important therapeutic options for cases of refractory glaucoma, in which trabeculectomy with antimetabolites has shown high risk of failure. There are devices with different sizes, designs and materials, and several studies have been conducted to test their safety and effectiveness. Despite known complications, their use has progressively increased in recent years, and they are the primary surgical option, in some situations. The aim of this review is to discuss the importance, mechanisms, biomaterials, results and complications of glaucoma drainage devices.

RESUMO Os dispositivos de drenagem para glaucoma são importante opção terapêutica em casos de glaucomas refratários, nos quais a trabeculectomia com antimetabólitos tem alta chance de falência. Há dispositivos com diferentes tamanhos, desenhos e materiais, e muitos estudos foram realizados para testar sua segurança e eficácia. Apesar de suas conhecidas complicações, seu uso tem aumentado progressivamente nos últimos anos, inclusive como primeira opção cirúrgica, em algumas situações. O objetivo desta revisão foi discutir a importância, os mecanismos, os biomateriais, os resultados e as complicações dos dispositivos de drenagem para glaucoma.

Prolene Canalostenting in Deep Sclerectomy: A Pilot Study.

PURPOSE: To study the effect of implantation of a 5/0 prolene suture segment inside Schlemm's canal as an adjunct to deep sclerectomy. MATERIALS AND METHODS: This was a prospective, interventional case series of nine eyes of six patients with open angle glaucoma. Patients underwent deep sclerectomy with insertion of a segment of 5/0 prolene into Schlemm's canal at the filtration site without suturing. The main outcome measures were: Intraocular pressure (IOP), postoperative interventions, and complications. Ultrasound biomicroscopy of the filtration area as well as the prolene suture was performed at 6 months postoperatively. RESULTS: Patients were followed for a mean of 8.1 ± 4.5 months. Mean IOP decreased statistically significant from 19 ± 4.2 mmHg preoperatively to 12 mmHg at 15 months postoperatively (P < 0.0001). The number of glaucoma medications was reduced from 3.7 ± 0.7 preoperatively to 0 postoperatively. No postoperative complications were noted. IOP remained in the low teens in all patients out to the last postoperative visit. Yttrium-aluminum-garnet laser goniopuncture was not required in any case. CONCLUSION: Implantation of a 5/0 prolene suture in Schlemm's canal during deep sclerectomy was a safe, cost-effective adjunct to maintain the patency of the intrascleral space and Schlemm's canal thus controlling IOP for 6 months postoperatively.