Dataset Information

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety.

ABSTRACT:

Purpose

To compare the efficacy and safety of the PRESERFLO™ MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG) after one year.

Patients and methods

Institutional prospective interventional cohort study comparing eyes with POAG, which had received the PRESERFLO™ MicroShunt versus trabeculectomy. The MicroShunt group was matched with the trabeculectomy group for age, known duration of disease, and number and classes of intraocular pressure (IOP) lowering medications to have similar conjunctival conditions. The study is part of the Dresden Glaucoma and Treatment Study, using a uniform study design, with the same inclusion and exclusion criteria, follow-ups and standardized definitions of success and failure for both procedures.

Primary outcome measures

mean diurnal IOP (mdIOP, mean of 6 measurements), peak IOP, and IOP fluctuations.

Secondary outcome measures

success rates, number of IOP lowering medications, visual acuity, visual fields, complications, surgical interventions, and adverse events.

Results

Sixty eyes of 60 patients, 30 in each group, were analyzed after 1-year follow-ups. Median [Q25, Q75] mdIOP (mmHg) dropped from 16.2 [13.8-21.5] to 10.5 [8.9-13.5] in the MicroShunt and from 17.6 [15.6-24.0] to 11.1 [9.5-12.3] in the trabeculectomy group, both without glaucoma medications. Reduction of mdIOP (P = .596), peak IOP (P = .702), and IOP fluctuations (P = .528) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy group, especially in the early postoperative period (P = .018). None of the patients experienced severe adverse events.

Conclusion

Both procedures are equally effective and safe in lowering mdIOP, peak IOP and IOP fluctuations in patients with POAG, one year after surgery.

Clinical trial registration

NCT02959242.

SUBMITTER: Jamke M

PROVIDER: S-EPMC10155172 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety.

Jamke Melanie M Herber Robert R Haase Maike A MA Jasper Carolin S CS Pillunat Lutz E LE Pillunat Karin R KR

Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie 20230503 10

<h4>Purpose</h4>To compare the efficacy and safety of the PRESERFLO™ MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG) after one year.<h4>Patients and methods</h4>Institutional prospective interventional cohort study comparing eyes with POAG, which had received the PRESERFLO™ MicroShunt versus trabeculectomy. The MicroShunt group was matched with the trabeculectomy group for age, known duration of disease, and number and classes of intraocular pressure (IOP) lo ...[more]

PMID: 37133501

Similar Datasets

Project description:IntroductionThe implantation of the PRESERFLO™ MicroShunt (PMS) device has been shown to significantly lower increased intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). However, guidelines on best practice for patient selection and pre-/peri-/postoperative care management are lacking. The aim of this modified Delphi panel was to achieve expert consensus on the role of the PMS to treat patients with glaucoma in Europe.MethodsTwelve European glaucoma surgeons experienced with the PMS procedure participated in a three-round modified Delphi panel. A targeted literature review and expert steering committee guided round 1 questionnaire development. Consensus was set at a pre-defined threshold of at least 70% of panellists selecting 'Strongly disagree'/'Disagree' or 'Strongly agree'/'Agree' for six-point Likert scale questions, or at least 70% selecting the same option for multiple-choice questions. Questions not reaching consensus were restated/revised for the next round, following guidance from free-text responses/scoping questions.ResultsConsensus was achieved for 60.3% (n = 38/63), 60.0% (n = 18/30), and 100.0% (n = 11/11) of Likert/multiple-choice questions in rounds 1, 2, and 3, respectively. There was agreement that the PMS procedure is effective at reducing IOP in patients with high-tension POAG (greater than 21 mmHg). Although surgical techniques may vary slightly, consensus was reached on several points, including the importance of posterior application of mitomycin C (MMC). Panellists agreed that the PMS postoperative follow-up appointment schedule is reasonably predictable and mostly characterised by fewer visits than with trabeculectomy, particularly in the early phase. Although panellists agreed that combined cataract/PMS surgery and the use of non-MMC wound-healing modulators/antifibrotics during the procedure are possible, further data are needed to determine efficacy.ConclusionThe expert consensus reached in this panel will help inform best practice guidelines in the treatment of patients with glaucoma in Europe. Panellists also highlighted key areas for future research to improve understanding of the PMS in the treatment algorithm of glaucoma.

Dataset Information

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety.

Purpose

Patients and methods

Primary outcome measures

Secondary outcome measures

Results

Conclusion

Clinical trial registration

Publications

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety.

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