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Observational Study
. 2024 Jan;38(1):103-111.
doi: 10.1038/s41433-023-02642-5. Epub 2023 Jul 6.

Effectiveness and safety of XEN45 implant over 12 months of follow-up: data from the XEN-Glaucoma Treatment Registry

Francesco Oddone  1 , Gloria Roberti  2 , Sara Giammaria  2 , Chiara Posarelli  3 , Giorgio Ghirelli  4 , Leonardo Mastropasqua  5 , Luca Agnifili  5 , Tommaso Micelli Ferrari  6 , Vincenzo Pace  6 , Paolo Nucci  7 , Matteo Sacchi  8 , Gianluca Monsellato  8 , Romeo Altafini  9 , Gianluca Scuderi  10 , Andrea Perdicchi  10 , Maurizio Uva  11 , Carmela Carnevale  2 , Giuseppe Covello  3 , Maria Novella Maglionico  3 , Antonio Fea  12 , Michele Figus  3
Affiliations
Observational Study

Effectiveness and safety of XEN45 implant over 12 months of follow-up: data from the XEN-Glaucoma Treatment Registry

Francesco Oddone et al. Eye (Lond). 2024 Jan.

Abstract

Objectives: To evaluate the 1-year effectiveness and safety of the XEN45, either alone or in combination with phacoemulsification, in glaucoma patients.

Methods: This multicentre, prospective, observational study included consecutive eyes of glaucoma patients from the Italian XEN-Glaucoma Treatment Registry (XEN-GTR) who underwent XEN45 alone or in combination with phacoemulsification, with at least 1 year of follow-up. Surgical success was defined as intraocular pressure (IOP) < 18 mmHg and ≥20% reduction from preoperative IOP, over 1 year of follow-up.

Results: Two hundred thirty-nine eyes (239 patients) were analyzed, 144 (60.2%) eyes in the XEN-solo and 95 (39.8%) eyes in the XEN+Phaco groups. One hundred-sixty-eight (70.3%) eyes achieved overall success, without statistically significant differences between study groups (p = 0.07). Preoperative IOP dropped from a median (IQR) of 23.0 (20.0-26.0) mmHg to 14.0 (12.0-16.0) mmHg at month 12 (p < 0.001), with overall 39.9 ± 18.3% IOP reduction. The mean number of preoperative ocular hypotensive medications (OHM) was significantly reduced from 2.7 ± 0.9 to 0.5 ± 0.9 at month 12 (p < 0.001). Preoperative IOP < 15 mmHg (HR: 6.63; 95%CI: 2.61-16.84, p < 0.001) and temporal position of the surgeon (HR: 4.25; 95%CI: 2.62-6.88, p < 0.001) were significantly associated with surgery failure. One hundred-forty-six (61.1%) eyes had no intraoperative complications, whereas 91 (38.1%) and 56 (23.4%) eyes experienced at least one complication, respectively early (< month 1) and late (≥ month 1), all self-limiting or successfully treated without sequelae. Needling occurred in 55 (23.0%) eyes at least once during follow-up.

Conclusion: Over 1-year follow-up, XEN45 alone or in combination with phacoemulsification, had comparable success rates and effectively and safely lowered IOP and the need for OHM.

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Conflict of interest statement

FO: Allergan Abbvie, Santen. PN: Thea, Santen, Hoya. AF: Allergan Abbvie, Glaukos, Ivantis, EyeD. GR; SG; CP; GG; LA; TMF; LM; VP; MS; GM; RA; GS; AP; MU; CC; MM; MF: none.

Figures

Fig. 1
Fig. 1. Distribution of intraocular pressure (IOP) and ocular hypotensive medications (OHM).
At preoperative visit and through the 12 months of follow-up in the overall study sample (A) and in the XEN alone and the XEN+Phaco groups (B). Boxes represent the first and third quartiles and the horizontal lines across the boxes indicate the median.
Fig. 2
Fig. 2. Scatter plot of the intraocular pressure (IOP) at preoperative visit vs. IOP at month 12, according to the preoperative IOP and number of ocular hypotensive medications.
Each point represents one eye. The horizontal gray lines represent the IOP thresholds at month 12. The black lines represent the percentage levels of IOP reduction at month 12 compared with preoperative IOP. Eyes with missing IOP data are not shown. OHM ocular hypotensive medications.
Fig. 3
Fig. 3. Kaplan–Meier survival curves.
The success probability through the 12 months of follow-up, in the overall study sample (A) and in the XEN alone and the XEN+Phaco groups (B) and multivariate Cox proportional hazard ratios and 95% confidence intervals (CIs) for preoperative (C) and intraoperative (D) factors predictive of surgical failure. In survival curves, eyes lost to follow-up before month 12 and that did not meet the failure criteria were censored. F female, M male, PFX pseudoexfoliation glaucoma, IOP intraocular pressure, VF visual field, OHM ocular hypotensive medications, SN supero-nasal.
See this image and copyright information in PMC

References

    1. Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: A review. JAMA. 2014;311:1901–11. - PMC - PubMed
    1. Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, et al. Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001;108:1943–53. - PubMed
    1. Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, et al. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015;122:1308–16. - PMC - PubMed
    1. Musch DC, Gillespie BW, Lichter PR, Niziol LM, Janz NK. Visual Field Progression in the Collaborative Initial Glaucoma Treatment Study. The Impact of Treatment and Other Baseline Factors. Ophthalmology. 2009;116:200–7. - PMC - PubMed
    1. Burr J, Azuara-Blanco A, Avenell A. Medical versus surgical interventions for open angle glaucoma. Cochrane Database of Systematic Reviews. 2004:CD004399. 10.1002/14651858.CD004399.pub2. - PubMed

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