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Clinical science
Efficacy and safety data for the XEN45 implant at 2 years: a retrospective analysis
  1. Itay Elimelech Gabbay1,2,3,
  2. Felicity Allen1,
  3. Christine Morley1,
  4. Tahmina Pearsall4,
  5. Oliver Martyn Bowes1,
  6. Simon Ruben1
  1. 1Ophthalmology, Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea, UK
  2. 2Ophthalmology, Rabin Medical Center, Petah Tikva, Israel
  3. 3Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
  4. 4Ophthalmology, Whipps Cross University Hospital, London, UK
  1. Correspondence to Dr Itay Elimelech Gabbay, Ophthalmology, Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea, SS0 0RY, UK; igabbay{at}gmail.com

Abstract

Aim To report efficacy and safety measures for XEN45 in a National Health Service setting after 24-month follow-up.

Methods This is a retrospective, non-comparative audit of records of patients who underwent XEN45 procedure between June 2015 and May 2017. The main outcome measures were intraocular pressure (IOP) reduction and number of antihypertensive medications at each timepoint. Failure was defined as requiring further surgery or removal of XEN. Success was defined as 20% reduction of IOP without additional glaucoma medications or reduction in antihypertensive medications without increase in baseline IOP. Needling rates were assessed and subgroup analysis was performed.

Results A total of 151 eyes were included in the study. The main diagnoses were primary open angle glaucoma (84.1%), angle closure glaucoma (8.6%) and refractory glaucoma (7.3%). Stand-alone procedure was performed in 62.3% and combined phaco-XEN was done in 37.7%. The mean IOP at baseline was 22.1±6.5 mm Hg, and the mean IOP at 12 and 24 months was 15.4±5.9 mm Hg and 14.5±3.3 mm Hg, respectively (p<0.001). The mean number of medications was 2.77±1.1 at baseline, and 0.3±0.7 and 0.5±1.0 medications at 12 and 24 months, respectively (p<0.001). 25% of patients failed at the 24-month timepoint. Needling was required in 37.7% of patients at 24 months. Non-Caucasian ethnicity was found to be related to higher failure rate. No significant adverse events were noted.

Conclusion XEN45 is a viable, effective and safe procedure after 2 years of follow-up. Patients should be advised regarding failure rate as well as possible need for bleb revisions and medication use.

  • glaucoma
  • treatment surgery
  • intraocular pressure

https://doi.org/10.1136/bjophthalmol-2019-313870

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    Footnotes

    • Contributors IEG: conception and design, analysis and interpretation, writing, critical revision, final approval, statistics, literature search, administrative support. FA: data collection, analysis and interpretation, writing, literature search. CM: data collection, administrative support. TP: conception and design, data collection. OMB: data collection. SR: conception and design, analysis and interpretation, critical revision, final approval.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The audit was approved by the Southend University Hospital audit committee, tenets of the Declaration of Helsinki were strictly upheld.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon request.