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Keywords = PreserFlo MicroShunt

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25 pages, 1333 KB  
Systematic Review
MIGS, Cataract Surgery, or Both? An Analysis of Clinical Trial Data to Compare Efficacy and Outcomes on Glaucoma Patients
by Jeremy Appelbaum, Abdullah Virk, Deepkumar Patel and Karen Allison
J. Clin. Transl. Ophthalmol. 2025, 3(4), 20; https://doi.org/10.3390/jcto3040020 - 28 Sep 2025
Abstract
Background: Glaucoma is the leading cause of irreversible blindness around the world and is characterized as a group of irreversible optic neuropathies with multiple risk factors such as age, race/ethnicity, sex, and intraocular pressure (IOP), amongst many others that play a role in [...] Read more.
Background: Glaucoma is the leading cause of irreversible blindness around the world and is characterized as a group of irreversible optic neuropathies with multiple risk factors such as age, race/ethnicity, sex, and intraocular pressure (IOP), amongst many others that play a role in disease etiology. However, IOP is the only modifiable risk factor, with higher IOP often causing increased damage to the optic nerve, resulting in the vast majority of medical and surgical treatments aiming to reduce IOP. There are a number of interventions available to treat glaucoma including micro-invasive glaucoma surgery (MIGS), whose usage has drastically increased due to its safety and efficacy. Studies also highlight the IOP-reducing effect of cataract surgery, which is the most common procedure performed globally. However, other, more targeted therapies and surgeries have been shown to have a more significant effect on IOP reduction. The objective of this study is to compare the IOP and medication reduction between cataract surgery (CS), MIGS, and MIGS and cataract surgery (MACS) clinical trials. Methods: This analysis consisted of publicly available data on CS, MIGS, and MACS clinical trials from 2005 to 2017 using ClinicalTrials.gov. Data reporting and synthesis adhered to PRISMA guidelines. MIGS interventions studied in this analysis include iStent®, CyPass® Micro-Stent, Ex-PRESS®, Hydrus®, PRESERFLO MicroShunt, and XEN® Gel Stent. The main variables of interest are the mean IOP and mean number of glaucoma medications used. The primary outcomes were the baseline, post-procedure, and reduction in IOP and glaucoma medication use. Cohorts were further subdivided by the follow-up period (6, 12, and 24 months), as well as their medicated or unmedicated status for pre-op IOP measurement. PROSPERO CRD42025102892. Results: A total of 21 trials were included in this review, comprising 3330 clinical trial participants: 7 CS trials (N = 570), 13 MIGS trials (N = 1577), and 9 MACS trials (N = 1183). All interventions studied resulted in a decrease in both the IOP and medication usage with varying degrees. At 12 months, the wash-out baseline IOP reduction (mmHg) was 6.9 (27.5%) for CS, 8.8 (34.0%) for MIGS, and 8.2 (32.6%) for MACS. The medication reduction was 0.8 (56.1%) following CS, 1.0 (39.5%) for MIGS, and 1.3 (86.4%) for MACS. At 24 months, the wash-out baseline IOP reduction was 6.3 (25.1%) for CS, 8.4 (33.1%) for MIGS, and 7.6 (30.1%) for MACS. At 24 months, the medication reduction was 0.9 (58.3%) for CS, 1.5 (79.8%) for MIGS, and 1.3 (86.1%) for MACS. Conclusions: The results indicate that CS, MIGS, and MACS all result in a decrease in the IOP and glaucoma medications; however, MIGS and MACS outperform CS in IOP and medication reduction. Adopting MIGS and MACS for patients with ocular hypertension or mild-to-moderate glaucoma will help improve patient outcomes through reducing the IOP and medication burden. Given that glaucoma affects certain populations to a greater degree, future research analyzing racial representation is critical in ensuring the appropriate applicability of clinical trial results toward diverse populations. Full article
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15 pages, 918 KB  
Article
Intraluminal 10-0 Nylon Stenting in PRESERFLO™ MicroShunt Surgery for Pseudoexfoliation Glaucoma
by Miranda Gehrke, Leonie F. Keidel, Lara Buhl, Siegfried G. Priglinger and Marc J. Mackert
J. Clin. Med. 2025, 14(17), 6224; https://doi.org/10.3390/jcm14176224 - 3 Sep 2025
Viewed by 467
Abstract
Background/Objectives: Early postoperative hypotony and complications like choroidal detachment can occur after Preserflo MicroShunt (MS) implantation in patients with pseudoexfoliation glaucoma (PEXG). To prevent these risks, outflow from the microshunt tube can be reduced by implementing a nylon stent. This study aims to [...] Read more.
Background/Objectives: Early postoperative hypotony and complications like choroidal detachment can occur after Preserflo MicroShunt (MS) implantation in patients with pseudoexfoliation glaucoma (PEXG). To prevent these risks, outflow from the microshunt tube can be reduced by implementing a nylon stent. This study aims to evaluate the impact of intraluminal stenting of the MS during the first four months after surgery. Methods: This retrospective study of 43 eyes investigated the incidence of intraocular hypotony in PEXG patients undergoing MS implantation with (n = 23) or without (n = 20) intraluminal stenting using a 10.0 nylon suture. The follow-up period was four months after surgery. Results: Our results demonstrated that intraluminal stenting significantly reduced the incidence of postoperative complications related to hypotony. Notably, no cases of choroidal detachment occurred in the nylon-stenting group (nsMS) compared to 30% (6 eyes) in the MS-only group (p = 0.0064). The hypotony rates between the nsMS (21.74%, 5 eyes) and the MS-only group (40%, 8 eyes) did not significantly differ (p = 0.3184). Both groups experienced significant reductions in intraocular pressure (p < 0.001) and a decrease in the number of antiglaucomatous medications (p < 0.001) up to four months after surgery. Conclusions: The use of an intraluminal stent (10.0 nylon suture) during MS implantation may be a promising strategy to reduce the risk of hypotony-related complications, particularly choroidal detachment, in patients with PEXG. Full article
(This article belongs to the Special Issue New Insights into Glaucoma)
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10 pages, 649 KB  
Article
Effect of Subconjunctival Healaflow in Filtrating Surgery with Preserflo MicroShunt in Primary Open Angle Glaucoma
by Leonie F. Keidel, Miranda Gehrke, Stefan Kassumeh, Lara Buhl, Siegfried G. Priglinger and Marc J. Mackert
J. Clin. Med. 2025, 14(17), 6000; https://doi.org/10.3390/jcm14176000 - 25 Aug 2025
Viewed by 501
Abstract
Background/Objectives: This work aims to clarify whether the subtenon use of the sodium hyaluronate product Healaflow in filtrating surgery with PreserFlo MicroShunt positively influences the early postoperative course in terms of control of intraocular pressure, hypotony, and needling rate. Methods: A [...] Read more.
Background/Objectives: This work aims to clarify whether the subtenon use of the sodium hyaluronate product Healaflow in filtrating surgery with PreserFlo MicroShunt positively influences the early postoperative course in terms of control of intraocular pressure, hypotony, and needling rate. Methods: A retrospective, randomized controlled, interventional, single-center trial was performed at the Ludwig Maximilians-University Munich from January 2024 to July 2024. Only patients with primary open angle glaucoma (POAG) were included. In all patients, a complete ophthalmological examination including best corrected visual acuity (BCVA), automated refraction, and Goldman tonometry was performed at 2 days, 1–4 and 5–8 weeks, and 3–4 and 5–6 months after surgery. Healaflow was injected underneath the tenon during filtrating surgery with PreserFlo MicroShunt in addition to mitomycin C (MMC). The Healaflow group was compared to a control group with POAG patients in which Healaflow was not used during surgery with PreserFlo MicroShunt and MMC. Results: A total of 45 eyes of 45 patients were included, with 20 eyes in the Healaflow group and 25 eyes in the control group. In both groups, a significant reduction in IOP and medication could be observed: complete surgical success (IOP ≥ 6 mm Hg and ≤17 mm Hg, without surgical complications or complete loss of vision) was reached in 88% of patients in the Healaflow group at the last follow-up. In 95% of patients in the control group, complete success could be observed. The success rates did not significantly differ between the two groups (p = 0.568). Hypotony rates were 35% in the Healaflow and 12% in the control group after two days (p = 0.083); the rates equalized after 1–4 weeks (p = 1). Needling rates were comparable between both groups (25% versus 20%, p = 0.731). Conclusions: PreserFlo MicroShunt implantation with MMC was equally effective in terms of reduction in IOP and medication in both scenarios with additional or without the use of Healaflow. Postoperative hypotony and needling rates did not significantly differ between the two groups. The additional effects of Healaflow on anti-scarring and maintaining space are likely too minimal to cause significant differences in IOP or medication when already treated with MMC. Full article
(This article belongs to the Section Ophthalmology)
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10 pages, 485 KB  
Article
Clinical Practice Preferences for Glaucoma Surgery in Japan in 2024
by Kentaro Iwasaki, Shogo Arimura, Yoshihiro Takamura and Masaru Inatani
J. Clin. Med. 2025, 14(6), 2039; https://doi.org/10.3390/jcm14062039 - 17 Mar 2025
Cited by 4 | Viewed by 1081
Abstract
Objectives: This study evaluated the clinical preferences of glaucoma specialists regarding glaucoma surgery and postoperative management in Japan in 2024. Methods: A survey about clinical practice preferences regarding glaucoma surgery and postoperative care was administered among 50 glaucoma specialists who were councilors in [...] Read more.
Objectives: This study evaluated the clinical preferences of glaucoma specialists regarding glaucoma surgery and postoperative management in Japan in 2024. Methods: A survey about clinical practice preferences regarding glaucoma surgery and postoperative care was administered among 50 glaucoma specialists who were councilors in the Japan Glaucoma Society. Results: Minimally invasive glaucoma surgery (MIGS) plus phacoemulsification was the most preferred procedure for nonoperated mild to moderate cases of primary open-angle glaucoma (POAG) (94.6%) and normal tension glaucoma (NTG) (67.3%) associated with cataract. Microhook surgery was the most preferred among the MIGS procedures. Meanwhile, PreserFlo MicroShunt (PMS) surgery is emerging as a popular option for cases of POAG and NTG, especially in advanced-stage pseudophakic eyes that underwent prior corneal incision phacoemulsification (40.1%). Long-tube shunt surgeries were predominantly preferred for POAG after two failed trabeculectomies (69.4%) and for neovascular glaucoma with prior vitrectomy after a failed trabeculectomy (73.0%). Among long-tube shunt surgeries, the Ahmed glaucoma valve (AGV) was preferred over the Baerveldt glaucoma implant. Trabeculectomy required the most frequent follow-up visits within the first postoperative year, whereas PMS and long-tube shunt surgeries required comparatively fewer follow-up visits. Overall, MIGS involved less frequent follow-up visits versus filtering surgeries. Conclusions: MIGS is currently the procedure of choice for primary glaucoma surgery in Japan. Among glaucoma specialists of the Japan Glaucoma Society, PMS surgery is becoming popular for cases of POAG and NTG. Refractory glaucoma is commonly treated with long-tube shunt surgeries, especially the AGV. Full article
(This article belongs to the Special Issue Clinical Debates in Minimally Invasive Glaucoma Surgery (MIGS))
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11 pages, 2022 KB  
Article
Preserflo-MicroShunt: Postoperative Effects on Endothelial Cell Density and Corneal Thickness
by Sebastian Dierse, Eliane Luisa Esser, Ralph-Laurent Merté, Sami Al-Nawaiseh, Martin Dominik Leclaire, Nicole Eter and Viktoria Constanze Brücher
Biomedicines 2025, 13(2), 364; https://doi.org/10.3390/biomedicines13020364 - 5 Feb 2025
Cited by 2 | Viewed by 1302
Abstract
Background: The aim of this study was to evaluate the effects of Preserflo implantation on endothelial cell density (ECD), corneal thickness, intraocular pressure (IOP), and the use of antiglaucoma medications over a 12-month follow-up period. Methods: A total of 53 eyes from 53 [...] Read more.
Background: The aim of this study was to evaluate the effects of Preserflo implantation on endothelial cell density (ECD), corneal thickness, intraocular pressure (IOP), and the use of antiglaucoma medications over a 12-month follow-up period. Methods: A total of 53 eyes from 53 patients undergoing Preserflo implantation were included in this prospective study. ECD, corneal thickness, IOP, and the number of antiglaucoma medications were measured at baseline, 3 months, and 12 months postoperatively. Statistical analysis was performed using paired t-tests and Wilcoxon signed-rank tests for non-normally distributed data. Results: There was no significant reduction in ECD at 3 months (p = 0.695) or 12 months (p = 0.229) compared to baseline. However, a significant reduction in corneal thickness was observed at 3 months (p = 0.008), with no significant change at 12 months (p = 0.118). A significant reduction in IOP was noted at both 3 months (from a preoperative median of 23.5 mmHg to 11.5 mmHg, p < 0.001) and 12 months (from 23.5 mmHg to 13.0 mmHg, p < 0.001). Additionally, there was a significant decrease in the use of antiglaucoma medications, from a preoperative median of 3.0 medication classes to 0.0 classes at both 3 months (p < 0.001) and 12 months (p < 0.001). Conclusions: Preserflo implantation resulted in a significant reduction in IOP and the need for antiglaucoma medications, with no significant impact on endothelial cell density and corneal thickness after 12 months. These findings suggest that Preserflo implantation is an effective procedure for IOP control and medication reduction, with favorable outcome for corneal health after one year. Full article
(This article belongs to the Special Issue Glaucoma: New Diagnostic and Therapeutic Approaches, 2nd Edition)
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14 pages, 1608 KB  
Article
Short-Term Safety and Efficacy of PreserFlo™ Microshunt in Patients with Refractory Intraocular Pressure Elevation After Dexamethasone Implant Intravitreal Injection
by Leonie Bourauel, Michael Petrak, Frank G. Holz, Karl Mercieca and Constance Weber
J. Clin. Med. 2025, 14(2), 507; https://doi.org/10.3390/jcm14020507 - 14 Jan 2025
Cited by 1 | Viewed by 1455
Abstract
Background: The PreserFlo™ MicroShunt (PFMS) is a bleb-forming device considered to be less invasive than traditional glaucoma surgery such as trabeculectomy. This study evaluates the 1-year success rates as well as safety profile of PFMS in patients having high intraocular pressure (IOP) [...] Read more.
Background: The PreserFlo™ MicroShunt (PFMS) is a bleb-forming device considered to be less invasive than traditional glaucoma surgery such as trabeculectomy. This study evaluates the 1-year success rates as well as safety profile of PFMS in patients having high intraocular pressure (IOP) and/or glaucoma refractory to drop therapy with a history of prior intravitreal dexamethasone therapy. Methods: A total of 16 eyes after PFMS implantation due to elevated IOP after intravitreal dexamethasone implant (DEX-I) administration were included in this retrospective cohort study. Success rates and secondary outcomes were evaluated. Results: Qualified and complete success rates at 12 months, respectively, were 14/16 and 12/16 eyes for criterion A, 13/16 and 11/16 eyes for B, 13/16 and 11/16 eyes for C, and 6/16 and 6/16 eyes for D. The overall mean (range) preoperative IOP decreased from 27 (16–38) mmHg to 13 (10–17) mmHg at 12 months. BCVA was not significantly different up to 12 months (p = 0.63). The preoperative mean (range) number of medications decreased from 3.56 (2–4) to 0.31 (0–3) at 12 months. One eye underwent needling twice, and two eyes were revised surgically. One patient needed replacement of the PFMS. There were no hypotony-related complications. Conclusions: The PFMS is an effective surgical option for patients with steroid-induced IOP elevation. It demonstrates satisfactory short-term success rates, a reduced need for pressure-lowering eye drops, an excellent safety profile with minimal postoperative care, and a low complication rate. Additional interventions such as needling or revisions were infrequently necessary. However, PFMS may not be the ideal choice for cases requiring a low target pressure (≤12 mmHg). Full article
(This article belongs to the Special Issue Personalized Treatments for Glaucoma Patients)
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11 pages, 647 KB  
Article
Postoperative Outcomes of PreserFlo MicroShunt in Patients with Exfoliation Glaucoma
by Hiroyuki Wakuda, Ryota Aoki and Shunsuke Nakakura
J. Clin. Med. 2024, 13(20), 6132; https://doi.org/10.3390/jcm13206132 - 15 Oct 2024
Cited by 2 | Viewed by 2297
Abstract
Objectives: This study aimed to evaluate the postoperative outcomes of the PreserFlo MicroShunt in Asian patients with exfoliation glaucoma. Methods: We used the Kaplan–Meier method to analyze 29 eyes of 29 patients with exfoliation glaucoma (mean age: 80.7 ± 8.3 years; [...] Read more.
Objectives: This study aimed to evaluate the postoperative outcomes of the PreserFlo MicroShunt in Asian patients with exfoliation glaucoma. Methods: We used the Kaplan–Meier method to analyze 29 eyes of 29 patients with exfoliation glaucoma (mean age: 80.7 ± 8.3 years; 16 males; 24 eyes with intraocular lens implants; preoperative intraocular pressure [IOP]: 32.5 ± 9.3 mmHg; preoperative antiglaucoma medications: 3.4 ± 1.0; Asian ethnicity: 100%) who underwent PreserFlo MicroShunt surgery alone at Saneikai Tsukazaki Hospital from November 2022 to November 2023. The criteria for survival were a reduction in IOP of ≥20%, no additional glaucoma surgery, and IOP of 5–21 mmHg (condition 1), 5–18 mmHg (condition 2), and 5–15 mmHg (condition 3). Needling and glaucoma eye drops were considered qualified successes. Results: The mean follow-up period was 27.9 weeks, with a reoperation rate of 31% (9 cases). The complete and qualified success survival rates at 24 weeks were 56%, 52%, and 49%, and 67%, 59%, and 53% for conditions 1–3, respectively. The complete and qualified success survival rates at 48 weeks were 47%, 43%, and 45%, and 52%, 46%, and 48% for conditions 1–3, respectively. Conclusions: The postoperative outcomes of the PreserFlo MicroShunt in Asian patients with exfoliation glaucoma demonstrated an approximate 50% success rate at both 24 and 48 weeks, with a reoperation rate of approximately 30%. Caution is warranted when performing PreserFlo MicroShunt in patients with exfoliation glaucoma. Full article
(This article belongs to the Special Issue Clinical Debates in Minimally Invasive Glaucoma Surgery (MIGS))
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12 pages, 505 KB  
Article
Preserflo MicroShunt versus Trabeculectomy: Efficacy and Surgical Success within a Heterogenous Patient Cohort
by Lynn Anna Barbara Zweifel, Jens Julian Storp, Friederike Elisabeth Vietmeier, Moritz Fabian Danzer, Ralph-Laurent Merté, Nicole Eter and Viktoria Constanze Brücher
Life 2024, 14(9), 1171; https://doi.org/10.3390/life14091171 - 17 Sep 2024
Cited by 1 | Viewed by 2002
Abstract
To compare success rates of trabeculectomy (TE) and Preserflo MicroShunt (PMS) in heterogenous glaucoma cohorts with regards to different pre- and postoperative therapeutic regimens. Data of 187 glaucoma patients who either received TE (73 eyes) or PMS implantation (114 eyes) between January 2018 [...] Read more.
To compare success rates of trabeculectomy (TE) and Preserflo MicroShunt (PMS) in heterogenous glaucoma cohorts with regards to different pre- and postoperative therapeutic regimens. Data of 187 glaucoma patients who either received TE (73 eyes) or PMS implantation (114 eyes) between January 2018 and December 2022 were retrospectively evaluated. Surgical success and failure rates were analyzed within six months of follow-up. Intraocular pressure (IOP) development over the course of follow-up was compared between both groups. Tertiary outcome measures were best-corrected visual acuity (BCVA), number and type of medications, frequency of postoperative complications and revision surgeries. Outcome measures underwent additional assessment based on subgroup categorizations, and failure time hazard ratios were computed. The success rates were comparable between both procedures (TE: 54.1%, PMS: 60.0%; p = 0.17). Both procedures showed significant IOP reduction (p < 0.01); however, overall IOP reduction was greater in the TE group than in the PMS group (TE: Reduction by 12 mmHg (188.9%), PMS: Reduction by 7 mmHg (51.3%); p = 0.01). The number of topical medications decreased significantly in both groups over the course of follow-up (TE: 4 to 0, PMS: 3 to 0; p < 0.01). While the number of complications and revision surgeries were similar in both groups, the time interval until the first revision surgery within the TE group was significantly shorter (TE: 13.5 d, PMS: 163 d; p = 0.01) than within the PMS group. No difference could be detected between TE and PMS with regard to the follow-up regimen. In particular, there was no significant difference in the need for 5-floururacil injections postoperatively (p = 0.29). Less invasive glaucoma surgery with the PMS appeared comparable to the TE within a heterogenous glaucoma cohort with regards to IOP development and freedom from medication. Full article
(This article belongs to the Collection New Diagnostic and Therapeutic Developments in Eye Diseases)
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8 pages, 1431 KB  
Article
Assessing the Impact of PRESERFLO MicroShunt on Intraocular Pressure in Porcine Eyes Ex Vivo Using Infusion Pump System
by Andi Masdipa, Sachiko Kaidzu and Masaki Tanito
Bioengineering 2024, 11(7), 669; https://doi.org/10.3390/bioengineering11070669 - 29 Jun 2024
Cited by 1 | Viewed by 1536
Abstract
To evaluate the effectiveness of the PRESERFLO MicroShunt (PFM) in reducing intraocular pressure (IOP) ex vivo in porcine eyes using an infusion pump system and to simulate various IOP conditions, In this study, porcine eyes received increasing flows between 2 and 20 μL/min. [...] Read more.
To evaluate the effectiveness of the PRESERFLO MicroShunt (PFM) in reducing intraocular pressure (IOP) ex vivo in porcine eyes using an infusion pump system and to simulate various IOP conditions, In this study, porcine eyes received increasing flows between 2 and 20 μL/min. IOP measurements were taken under conditions with and without the PFM [PFM (+) and PFM (−), respectively]. In the PFM (−) group, IOP increased from 7.4 mmHg to 46.3 mmHg as the flow rate increased from 2 μL/min to 20 μL/min. The rate of IOP reduction (%ΔIOP) rose with increasing flow rates, although the absolute IOP values achieved with the PFM insertion also increased. The correlation between IOPs in the PFM (−) conditions and the %ΔIOP was modeled as %ΔIOP = 22.4 Ln [PFM(−) IOP] − 41.7. According to this equation, IOP reduction by PFM insertion is 0% at IOPs of 6.4 mmHg or lower. IOP reductions of 10%, 20%, 30%, and 40% were observed when the pre-insertion IOPs were 10.1, 15.7, 24.6, and 38.4 mmHg, respectively. Achievable post-insertion IOP levels of ≤21 mmHg, ≤18 mmHg, ≤15 mmHg, and ≤12 mmHg corresponded to the initial IOPs of 33 mmHg, 26 mmHg, 20 mmHg, and 14.8 mmHg, respectively. In conclusion, the PFM effectively reduced IOP within a specific range of IOP values in an ex vivo experimental system. In clinical situations, the PFM is unlikely to be effective at low IOP levels. At higher levels, the PFM reduces IOP, but it may be insufficient to achieve the target IOP. Full article
(This article belongs to the Special Issue Recent Advances and Trends in Ophthalmic Diseases Treatment)
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12 pages, 1102 KB  
Article
PRESERFLO™ Microshunt: 1-Year Results of a 25-Gauge vs. 27-Gauge Needle Tract
by Stefan Steiner, Hemma Resch, Barbara Kiss and Clemens Vass
J. Clin. Med. 2024, 13(7), 1979; https://doi.org/10.3390/jcm13071979 - 29 Mar 2024
Cited by 3 | Viewed by 1396
Abstract
Background: The purpose of this study was to evaluate the effectiveness and safety of the PreserFlo™ microshunt (PMS) using a 25-Gauge vs. 27-Gauge needle tract. Methods: This is a prospective postoperative examination of 60 glaucoma eyes that received a PMS. The main [...] Read more.
Background: The purpose of this study was to evaluate the effectiveness and safety of the PreserFlo™ microshunt (PMS) using a 25-Gauge vs. 27-Gauge needle tract. Methods: This is a prospective postoperative examination of 60 glaucoma eyes that received a PMS. The main outcome measures were intraocular pressure (IOP), glaucoma drug score (GDS), Kaplan–Meier success rates, complications, and secondary intervention rates. Two subgroups were formed for data comparison: 27-Gauge (27G), and 25-Gauge (25G). Success was defined as IOP < 18 mmHg together with ≥20% IOP reduction with medication allowed (qualified success = QS18) or not (full success = FS18). Results: IOP and GDS were reduced from baseline to the 1-year study visit as follows: All eyes from 23.4 ± 8.6 mmHg (3.1 ± 0.9) to 15.1 ± 5.9 mmHg (0.8 ± 1.1); 25G from 24.2 ± 7.3 mmHg (3.0 ± 0.8) to 12.7 ± 2.7 mmHg (0.5 ± 0.8); and 27G from 23.1 ± 9.2 mmHg (3.1 ± 1.0) to 16.2 ± 6.7 mmHg (0.9 ± 1.2). IOP at one year was lower in the 25G group compared to the 27G group (p = 0.035). Bleb needling was required in eight (13.3%) eyes and open bleb revisions in three (5.0%). Transient hypotony occurred in 21% and choroidal effusion in 8% of all eyes. Choroidal effusions were more frequent in the 25G group (21%) compared to the 27G group (2%, p = 0.031). One-year success rates were significantly higher in the 25G group compared to the 27G group for both QS18 (25G: 67.9% vs. 27G: 35.7%, p = 0.002) and FS18 (25G: 63.6% vs. 27G: 29.2%, p = 0.007). Conclusions: The PreserFlo microshunt is an effective and safe glaucoma surgery with a low rate of bleb revisions or needlings. We show that the 25G needle tract might be more efficient for IOP control at the cost of increased IOP-related complications compared to 27G. Full article
(This article belongs to the Section Ophthalmology)
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12 pages, 2119 KB  
Article
The Preserflo MicroShunt Affects Microvascular Flow Density in Optical Coherence Tomography Angiography
by Jens Julian Storp, Hannah Schatten, Friederike Elisabeth Vietmeier, Ralph-Laurent Merté, Larissa Lahme, Julian Alexander Zimmermann, Verena Anna Englmaier, Nicole Eter and Viktoria Constanze Brücher
Biomedicines 2023, 11(12), 3254; https://doi.org/10.3390/biomedicines11123254 - 8 Dec 2023
Cited by 2 | Viewed by 1510
Abstract
Intraocular pressure (IOP) lowering surgery has been shown to alter microvascular density in glaucoma patients. The aim of this study is to report changes in retinal flow density (FD) over the course of treatment with the Preserflo MicroShunt, using optical coherence tomography angiography [...] Read more.
Intraocular pressure (IOP) lowering surgery has been shown to alter microvascular density in glaucoma patients. The aim of this study is to report changes in retinal flow density (FD) over the course of treatment with the Preserflo MicroShunt, using optical coherence tomography angiography (OCTA). 34 eyes from 34 patients who underwent Preserflo MicroShunt implantation were prospectively enrolled in this study. OCTA imaging was conducted at the superficial (SCP), deep (DCP) and radial peripapillary plexus (RPC) levels. The progression of FD and IOP was assessed at different time points from baseline to six months postoperatively for the entire patient population, as well as disease severity subgroups. The Preserflo MicroShunt achieved a significant reduction in IOP over the course of six months (median: 8 mmHg; p < 0.01). FD values of the SCP and DCP did not show significant fluctuations, even after adjusting for disease severity. FD of the RPC decreased significantly over the course of six months postoperatively from 42.31 at baseline to 39.59 at six months postoperatively (p < 0.01). The decrease in peripapillary FD was strongest in patients with advanced glaucoma (median: −3.58). These observations hint towards dysfunctional autoregulatory mechanisms in capillaries surrounding the optic nerve head in advanced glaucoma. In comparison, the microvascular structure of the macula appeared more resilient to changes in IOP. Full article
(This article belongs to the Special Issue Glaucoma: New Diagnostic and Therapeutic Approaches)
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11 pages, 2535 KB  
Article
Exploring the Pressure Characteristics of the PRESERFLO MicroShunt in In Vitro Studies and Effects of Sclera on Device Performance
by Andi Masdipa, Sachiko Kaidzu and Masaki Tanito
J. Clin. Med. 2023, 12(23), 7266; https://doi.org/10.3390/jcm12237266 - 23 Nov 2023
Cited by 4 | Viewed by 1537
Abstract
This study aims to investigate the pressure characteristics of the PRESERFLO MicroShunt, a microinvasive glaucoma device, using an in vitro setup. Additionally, the study explores the impact of the scleral tissue surrounding the device on its pressure and lumen area. Ten PRESERFLO MicroShunts [...] Read more.
This study aims to investigate the pressure characteristics of the PRESERFLO MicroShunt, a microinvasive glaucoma device, using an in vitro setup. Additionally, the study explores the impact of the scleral tissue surrounding the device on its pressure and lumen area. Ten PRESERFLO MicroShunts were subjected to an in vitro experimental setup. A constant flow of physiological saline was maintained at 2 μL/min using an infusion syringe pump. The PRESERFLO was connected to a pressure transducer via a 23 G needle. Pressure characteristics were measured under three different conditions: without sclera [sclera (-)], passing through sclera at a 90° angle (sclera 90°), and passing through sclera at a 30° angle (sclera 30°). The lumen area of the device was measured using microscopic observation. We observed peak and trough pressures in this experimental setting; the peak pressure (6.76 mmHg) was significantly higher than the trough pressure of 4.74 mmHg (p = 0.0020) in the sclera (-) condition. Compared to sclera (-), the peak pressures were significantly higher in the sclera 90° (7.81 mmHg, p = 0.0020) and the sclera 30° (7.96 mmHg, p = 0.0039) conditions. Additionally, compared to sclera (-), the trough pressure was significantly higher in the sclera 90° (6.25 mmHg, p = 0.0039) and the sclera 30° (5.76 mmHg, p = 0.037) conditions. The lumen area was significantly smaller in the sclera 90° condition (3515 μm2) than the sclera (-) condition (3927 μm2, p = 0.0078). The study found that when the distal end of PRESERFLO MicroShunt was free and in air, it exhibited both peak and trough pressures. The presence of scleral tissue surrounding the PRESERFLO MicroShunt affects its lumen area and pressure characteristics. Understanding these effects can provide valuable insights into the device’s performance. Full article
(This article belongs to the Special Issue Innovation in Glaucoma: Imaging and Visual Function)
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12 pages, 15660 KB  
Article
Comparison of Bleb Morphology following PRESERFLO® MicroShunt and Trabeculectomy Using Anterior Segment OCT
by Somar M. Hasan, Theresa Theilig and Daniel Meller
Diagnostics 2023, 13(21), 3373; https://doi.org/10.3390/diagnostics13213373 - 2 Nov 2023
Cited by 4 | Viewed by 2475
Abstract
Trabeculectomy has traditionally been upheld as the gold standard in glaucoma surgery, but recent advancements, including the PRESERFLO® MicroShunt, have introduced less invasive techniques to mitigate complications and reduce intraocular pressure (IOP). The examination of bleb morphology post-filtering surgery is critical for [...] Read more.
Trabeculectomy has traditionally been upheld as the gold standard in glaucoma surgery, but recent advancements, including the PRESERFLO® MicroShunt, have introduced less invasive techniques to mitigate complications and reduce intraocular pressure (IOP). The examination of bleb morphology post-filtering surgery is critical for modulating wound healing and ensuring long-term success. While previous evaluations of PRESERFLO-generated blebs have relied on data from trabeculectomy blebs, the differing surgical techniques used in PRESERFLO and trabeculectomy surgeries suggest potential variations in bleb morphologies. This study conducted a comparative analysis of blebs resulting from PRESERFLO and trabeculectomy procedures. Retrospective descriptive assessments using the Jenaer Bleb Grading System were performed, along with quantitative evaluation using eight-dimensional parameters utilizing anterior segment OCT. We included 93 eyes (57 following PRESERFLO, 36 following trabeculectomy). In the descriptive assessment, PRESERFLO-generated blebs exhibited fewer conjunctival cysts (3.5% vs. 22.2%, p = 0.007) and cavernous changes (10.5% vs. 30.5%, p = 0.021) compared to trabeculectomy. Quantitatively, overall bleb dimensions were comparable (maximal bleb height, width, and length, p > 0.05 for all). However, PRESERFLO blebs displayed a shallower (0.52 ± 0.24 vs. 0.67 ± 0.3 mm, p = 0.017) yet longer (4.12 ± 1.54 vs. 3.23 ± 1.64 mm, p = 0.024) episcleral lake. A thicker bleb wall (1.52 ± 0.46 vs. 1.10 ± 0.37 mm, p < 0.001) along with more posteriorly positioned blebs (distance to limbus = 6.16 ± 1.36 vs. 4.87 ± 1.34 mm, p < 0.001) were observed following PRESERFLO. This study illuminates the nuanced morphological differences between PRESERFLO and trabeculectomy blebs. Understanding these distinctions is vital, empowering clinicians to make informed postoperative decisions and avoid misinterpretation of bleb morphology. Full article
(This article belongs to the Section Biomedical Optics)
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18 pages, 735 KB  
Review
Minimally Invasive Glaucoma Surgery: A Review of the Literature
by Michael Balas and David J. Mathew
Vision 2023, 7(3), 54; https://doi.org/10.3390/vision7030054 - 21 Aug 2023
Cited by 45 | Viewed by 10326
Abstract
Minimally invasive glaucoma surgery (MIGS) has emerged as a novel approach in the glaucoma treatment spectrum, offering a range of diverse procedures and devices aimed at reducing intraocular pressure (IOP). MIGS can be broadly classified into several categories: those that enhance trabecular outflow [...] Read more.
Minimally invasive glaucoma surgery (MIGS) has emerged as a novel approach in the glaucoma treatment spectrum, offering a range of diverse procedures and devices aimed at reducing intraocular pressure (IOP). MIGS can be broadly classified into several categories: those that enhance trabecular outflow (Trabectome, iStent, Hydrus Microstent, Kahook Dual Blade, high frequency deep sclerotomy, and gonioscopy-assisted transluminal trabeculotomy), those that augment suprachoroidal outflow (CyPass Microstent and iStent Supra), those that target Schlemm’s canal (TRAB360 and the OMNI Surgical System, Streamline, and Ab Interno Canaloplasty), and conjunctival bleb-forming procedures (EX-PRESS Glaucoma Filtration Device, Xen Gel Stent and PreserFlo MicroShunt). MIGS is considered to have a shorter surgical time and fewer severe complications when compared to traditional glaucoma surgeries such as trabeculectomy and glaucoma drainage device implantation (Ahmed, Baerveldt, and Molteno valves). This literature review comprehensively examines the distinct MIGS devices and procedures, their underlying mechanisms, and clinical outcomes, emphasizing the importance of evaluating the efficacy and complications of each approach individually. As the field of MIGS continues to evolve, it is crucial to prioritize high-quality, long-term studies to better understand the safety and effectiveness of these innovative interventions in glaucoma management. Full article
(This article belongs to the Special Issue Recent Advances in Glaucoma: Diagnosis and Treatment)
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12 pages, 928 KB  
Article
A Comparative Analysis of Morphology and Dimensions of Functional Blebs following PRESERFLO-Microshunt and XEN-Gel-Stent, a Study Using Anterior Segment OCT
by Somar M. Hasan, Theresa Theilig, Menelaos Papadimitriou and Daniel Meller
Diagnostics 2023, 13(14), 2318; https://doi.org/10.3390/diagnostics13142318 - 9 Jul 2023
Cited by 6 | Viewed by 2610
Abstract
Evaluation of bleb morphology is a vital part of successful filtration glaucoma surgery. The PRESERFLO-MicroShunt (PRESERFLO) and XEN-Gel-Stent (XEN) are drainage devices implanted using different surgical approaches (ab externo and ab interno, respectively), potentially resulting in distinct bleb morphology. Understanding these morphological differences [...] Read more.
Evaluation of bleb morphology is a vital part of successful filtration glaucoma surgery. The PRESERFLO-MicroShunt (PRESERFLO) and XEN-Gel-Stent (XEN) are drainage devices implanted using different surgical approaches (ab externo and ab interno, respectively), potentially resulting in distinct bleb morphology. Understanding these morphological differences is essential for postoperative care. In this study, we retrospectively examined functioning blebs following PRESERFLO and XEN implantation using high-resolution anterior segment OCT imaging. Qualitative assessment utilizing the Jenaer Bleb Grading System and quantitative assessment measuring 12 parameters representing bleb dimensions were conducted, and the results were compared between the two groups. A total of 80 eyes from 80 patients were included (41 after PRESERFLO, 39 after XEN). Functioning blebs following PRESERFLO exhibited a higher frequency of hyperreflective tenon changes compared to XEN (31.7% vs. 10.3%, respectively, p = 0.02) and a lower frequency of cavernous changes (17.1% vs. 35.9%, p = 0.05). Additionally, PRESERFLO blebs showed a higher frequency of visible episcleral lakes (92.7% vs. 30.8%, p < 0.001). Furthermore, PRESERFLO blebs demonstrated larger height (2.13 ± 0.5 vs. 1.85 ± 0.6 mm, p = 0.03), width (10.31 ± 2.3 vs. 9.1 ± 2.3 mm, p = 0.02), length (9.13 ± 1.8 vs. 8.24 ± 1.9 mm, p = 0.04), posterior location relative to the limbus (6.21 ± 1.2 vs. 5.21 ± 1.8 mm, p = 0.005), and a thicker bleb wall (1.60 ± 0.5 vs. 1.1 ± 0.4 mm, p = 0.004). Functioning blebs following PRESERFLO and XEN displayed morphological distinctions, likely attributed to variations in surgical techniques (ab externo vs. ab interno) and stent dimensions. These morphological differences should be taken into consideration when evaluating blebs, as they could impact assessments of bleb functionality and influence decisions regarding postoperative interventions. Full article
(This article belongs to the Special Issue Optical Coherence Tomography (OCT) Imaging in Ophthalmology)
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