Expert Consensus on the Use of the PRESERFLO™ MicroShunt Device in the Treatment of Glaucoma: A Modified Delphi Panel

Khawaja, Anthony P; Stalmans, Ingeborg; Aptel, Florent; Barton, Keith; Beckers, Henny J. M.; Klink, Thomas; Marchini, Giorgio; Casa, Jose Martinez de la; Simonsen, Jan Henrik; Töteberg‐Harms, Marc; Vass, Clemens; Pinto, Luís Abegão

doi:10.1007/s40123-022-00529-4

Cited by 4 publications

(12 citation statements)

References 21 publications

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“…The optimal MMC concentration in patients at risk for hypotony-related complications is still debated; some studies have shown an increased risk with a higher MMC concentration after trabeculectomy [ 31 , 32 ]. However, recent recommendations were not conclusive regarding the MMC concentration to use in PMS surgery and left the final decision to the surgeon’s own experience [ 5 ]. In our opinion, in PMS implantation, an intraluminal stent insertion might be preferable to a lower MMC concentration to avoid early hypotony.…”

Section: Discussionmentioning

confidence: 99%

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Systematic Preserflo MicroShunt Intraluminal Stenting for Hypotony Prevention in Highly Myopic Patients: A Comparative Study

Lupardi

Laffi

Moramarco

et al. 2023

JCM

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Transient hypotony is the most common early complication after Preserflo MicroShunt (PMS) implantation. High myopia is a risk factor for the development of postoperative hypotony-related complications; therefore, it is advisable that PMS implantation in patients should be performed while employing hypotony preventive measures. The aim of this study is to compare the frequency of postoperative hypotony and hypotony-related complications in high-risk myopic patients after PMS implantation with and without intraluminal 10.0 nylon suture stenting. This is a retrospective, case–control, comparative study of 42 eyes with primary open-angle glaucoma (POAG) and severe myopia that underwent PMS implantation. A total of 21 eyes underwent a non-stented PMS implantation (nsPMS), while in the remaining eyes (21 eyes), PMS was implanted with an intraluminal suture (isPMS group). Hypotony occurred in six (28.57%) eyes in the nsPMS group and none in the isPMS group. Choroidal detachment occurred in three eyes in the nsPMS group; two of them were associated with the shallow anterior chamber and one was associated with macular folds. At 6 months after surgery, the mean IOP was 12.1 ± 3.16 mmHg and 13.43 ± 5.22 mmHg (p = 0.41) in the nsPMS and isPMS group, respectively. PMS intraluminal stenting is an effective measure to prevent early postoperative hypotony in POAG highly myopic patients.

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Section: Discussionmentioning

confidence: 99%

“…Preserflo MicroShunt (PMS) (Santen Inc., Miami, FL, USA) implantation with mitomycin C (MMC) is considered a safe and effective surgical procedure for glaucoma patients [ 1 , 2 , 3 , 4 , 5 ]. However, postoperative complications may develop, leading to prolonged recovery and surgical failure in some cases.…”

Section: Introductionmentioning

confidence: 99%

Systematic Preserflo MicroShunt Intraluminal Stenting for Hypotony Prevention in Highly Myopic Patients: A Comparative Study

Lupardi

Laffi

Moramarco

et al. 2023

JCM

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“…As the PMS remains a relatively novel device to treat patients with glaucoma, key guidance and optimal approaches to its use are primarily guided by the real-world experience of surgeons. This modified Delphi panel successfully built on the results of the previous Delphi panel [ 11 ], achieving consensus from a group of glaucoma surgeons with extensive experience of the PMS to provide further detailed guidance on the use of the device to treat patients with glaucoma.…”

Section: Discussionmentioning

confidence: 99%

“…This study followed the methodology of the 2021 Delphi panel [ 11 ], consisting of 3 questionnaire rounds and a virtual consensus meeting held following Round 2 of the Delphi panel. The virtual consensus meeting enabled discussion among panellists regarding statements that had not yet reached consensus and provided additional context for statements that had already reached consensus.…”

Section: Methodsmentioning

confidence: 99%

“…An initial Delphi panel, conducted in 2021, evaluated best practice considerations among a group of 11 surgeons with experience using the PMS for the treatment of patients with glaucoma in Europe, with the primary focus of the consensus obtained to provide useful guidance for surgeons unfamiliar with the device [ 11 ]. Since the 2021 Delphi panel was conducted, further evidence on the efficacy and safety of the device has become available.…”

Section: Introductionmentioning

confidence: 99%

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Additional Guidance on the Use of the PRESERFLO™ MicroShunt in the Treatment of Glaucoma: Insights from a Second Delphi Consensus Panel

Khawaja,

Abegão Pinto,

Stalmans

et al. 2024

Ophthalmol Ther

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Introduction The PRESERFLO™ MicroShunt (PMS) has been proven to significantly lower intraocular pressure (IOP) in patients with glaucoma and has been available for use since 2019. With increasing published evidence and growing experience of glaucoma surgeons, the aim of this modified Delphi panel was to build on the findings of a previous Delphi panel conducted in 2021 and provide further guidance on the role of the PMS to treat patients with glaucoma in Europe. Methods Thirteen European glaucoma surgeons experienced in the PMS procedure participated in a 3-round modified Delphi panel. A targeted literature review and expert steering committee guided Round 1 questionnaire development. Consensus was pre-defined at a threshold of ≥ 70% of panellists selecting ‘strongly agree’/‘agree’ or ‘strongly disagree’/‘disagree’ for 6-point Likert scale questions or ≥ 70% selecting the same option for multiple or single-choice questions. Questions not reaching consensus were restated/revised for the next round, following guidance from freetext responses/scoping questions. Results In total, 28% ( n = 9/32), 52% ( n = 16/31) and 91% ( n = 10/11) of statements reached consensus in Rounds 1, 2 and 3, respectively. There was agreement that the PMS may be used in patients with pigmentary, post-trauma or post-vitrectomy glaucoma and for patients with uveitic glaucoma without active inflammation. The PMS may be more suitable for patients with contact lenses than other subconjunctival filtering surgeries, without eliminating bleb-associated risks. Consensus was reached that combining PMS implantation and phacoemulsification may be as safe as standalone PMS surgery, but further efficacy data are required. Following a late rise in IOP ≥ 4 months post-surgery, topical aqueous suppressant drops or bleb revision may be suitable management options. Conclusions This Delphi panel builds on the considerations explored in the 2021 Delphi panel and provides further detailed guidance for glaucoma surgeons on the use of the PMS, reflecting the availability of novel evidence and surgical experience. Videos are available for this article. Supplementary Information The online version contains supplementary material available at 10.1007/s40123-024-00902-5.

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The use of intraluminal PRESERFLO stenting in avoiding early postoperative hypotony

Verma-Fuehring,

Dakroub,

Bamousa

et al. 2024

Graefes Arch Clin Exp Ophthalmol

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Purpose Postoperative hypotony following PRESERFLO MicroShunt (PMS) implantation is a frequent cause of complications such as choroidal detachment and hypotony maculopathy. This study aims at evaluating the impact of intraluminal stenting of the PMS during the early postoperative period. Methods We retrospectively analyzed the data of 97 patients who underwent PMS implantation with intraoperative placement of a Nylon 10–0 suture as intraluminal stent (PStent) and compared the outcomes to those of an existing database of the traditional MicroShunt implantation technique (PTrad, n = 120). The primary outcome measure was the intraocular pressure (IOP) at one week postoperatively. As a secondary outcome measure, adverse hypotony, defined as an IOP ≤ 5 mmHg with significant choroidal effusion and/or anterior chamber shallowing or the presence of macular folds was also assessed. Additionally, the time to stent removal and the IOP one week after stent removal were reported. Results Preoperative median IOP was 25.0 (20.5–30.3) mmHg in PStent and 25.0 (19.3–32.0) mmHg in PTrad (p = 0.62). One week after surgery, the median IOP dropped to 10.0 (8.0–13.0) mmHg in PStent and 7.0 (5.0–9.0) in PTrad (p < 0.01). At one month, the IOP was 12.0 (10.0–14.0) mmHg in PStent and 10.0 (8.0–11.0) mmHg in PTrad (p < 0.01). After 3 months, both groups showed similar median IOP levels of 11.0 (8.0–13.5) mmHg and 10.0 (9.75–13.0) mmHg in PStent and PTrad, respectively (p = 0.66). The presence of adverse hypotony was significantly lower in PStent compared to PTrad (6.2% vs 15.8%, p < 0.05). In PStent the stent was removed after 30.0 (21.0–42.5) days. One week after stent removal the mean IOP drop was 6.1 ± 0.5 mmHg (p < 0.01). Conclusion In the early follow-up period, intraluminal stenting of the PMS appears to be safe and effective in controlling the IOP while reducing early postoperative hypotony. Surgical success is not compromised by stent placement. Based on our data, it is recommended to remove the suture two to six weeks after surgery for most patients with uncomplicated postoperative clinical findings.

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Expert Consensus on the Use of the PRESERFLO™ MicroShunt Device in the Treatment of Glaucoma: A Modified Delphi Panel

Cited by 4 publications

References 21 publications

Systematic Preserflo MicroShunt Intraluminal Stenting for Hypotony Prevention in Highly Myopic Patients: A Comparative Study

Systematic Preserflo MicroShunt Intraluminal Stenting for Hypotony Prevention in Highly Myopic Patients: A Comparative Study

Additional Guidance on the Use of the PRESERFLO™ MicroShunt in the Treatment of Glaucoma: Insights from a Second Delphi Consensus Panel

The use of intraluminal PRESERFLO stenting in avoiding early postoperative hypotony

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