Trial reportInternational ophthalmology2023
Theoretic scientific rationale of double XEN 45 Gel Stent implant in severe glaucomatous ocular hypertension.
Trial report in International ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Double implantation of Xen 45 gel stent in primary open-angle glaucoma: a pilot study.International ophthalmology · 2024Article
- Development and material characteristics of glaucoma surgical implants.Advances in ophthalmology practice and researchReview
- Advancing Glaucoma Treatment through Materials Science: A Bibliometric Analysis.Journal of current ophthalmologyArticle
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo investigate the theoretical hydrodynamic effects of a single or a double XEN 45 Gel Stent (XEN45) implant in glaucomatous eyes.
methodsA prospective non-randomized clinical study on 63 glaucomatous eyes of 63 patients. The preoperative intraocular pressure (IOP) values after 14 days of medical therapy washout was correlated to the postoperative IOP values 7 and 45 days after the implant of a XEN45. A mathematical model based on the Hagen-Poiseuille law was designed to assess the residual aqueous humor outflow (AHO) facility in glaucomatous eyes in function of the postoperative IOP reduction. Using XEN45 as unit of measurement, we transformed through equations the residual preoperative AHO in XEN45 equivalent in order to establish theoretical number of stents needed to reach the target IOP.
resultsThe mean preoperative washout IOP was 28.9 ± 5.4 mmHg, after 7 and 45 days the mean postoperative IOP was 12.6 ± 4.3 and 15.3 ± 4.4 mmHg, respectively (p < 0.001). A significant positive correlation was found between preoperative and postoperative IOP values. We obtained a mathematical relationship to estimate the theoretical number of XEN45 stents needed to reach the target IOP.
conclusionThe basal IOP (after medical therapy washout) is a predictive factor for the surgical success after a XEN45 implant. Establishing the residual preoperative AHO it is possible to predict the theoretical number of stents to implant. A double XEN45 implant could be considered a possible further tool to reach the target IOP in patients with severe AHO deficiency.
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