June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
One-Year Success of Stand-Alone Xen-45 Gel Implant Ab-Externo with Mitomycin-C and in Combination with Small Incision Cataract Surgery in Patients with Primary Open-Angle Glaucoma
Author Affiliations & Notes
  • Siddharth Bhargava
    Ophthalmology, Eastern Virginia Medical School, Norfolk, Virginia, United States
  • Fredric J Gross
    Ophthalmology, Eastern Virginia Medical School, Norfolk, Virginia, United States
  • Footnotes
    Commercial Relationships   Siddharth Bhargava None; Fredric Gross None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, OD39. doi:
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      Siddharth Bhargava, Fredric J Gross; One-Year Success of Stand-Alone Xen-45 Gel Implant Ab-Externo with Mitomycin-C and in Combination with Small Incision Cataract Surgery in Patients with Primary Open-Angle Glaucoma. Invest. Ophthalmol. Vis. Sci. 2023;64(8):OD39.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To report one-year outcomes of Xen-45 gel implant in patients with Primary open-angle glaucoma with or without concurrent small incision cataract surgery (SICS).

Methods : This is a retrospective chart review of POAG patients who underwent Xen-45 implantation with 0.4mg/mL mitomycin-C and with or without combined SICS between 2020-2021. All surgeries were performed by the second author. Only patients with at least one-year follow up and no previous glaucoma surgeries were included. Patients requiring additional surgical intervention were considered failures and not included for outcome analysis. Changes in the number of glaucoma medications and intraocular pressure (IOP) were recorded as primary outcomes. Changes in vision were a secondary outcome.

Results : A total of 258 patients with POAG who underwent Xen implant or combined SICS were reviewed. 31 patients were identified for analysis. 8 patients required additional surgery due to elevated IOP and were excluded. Statistical analysis of outcomes was performed on remaining 23 eyes (23 patients). The average age was 69 years(+/-12.8). 48%(n=11) were male. 52%(n=12) identified as Caucasian and 48% identified as African American. 13 patients(55%) underwent combined cataract and Xen surgery and 10(45%) had Xen implant alone. Average pre-op IOP was 22.8(+/-6.46) mmHg while using an average of 2.87(+/-1.42) glaucoma medications, whereas post-op IOP was 14.35mmHg (+/-2.29) with 1.26 medications(+/-1.36). Both reductions were statically significant(p<0.0001). BCVA (logMar) significantly improved in patients that had combined cataract and Xen surgery from 0.421 pre-op(+/-0.37) to 0.177(+/-0.11) post-op (p=0.224). BCVA was unchanged in the stand-alone Xen group from post-op (p>0.5). Early failure (IOP over 21 despite maximum medication) occurred significantly more frequently in African American eyes (n=6, 35%) when compared with Caucasian eyes(n=2, 14%)(p=0.0401).

Conclusions : The Xen-45 gel implant is safe and effective in lowering IOP and number of drops in patients with POAG when performed alone or in conjunction with SICS. African American patients appear to have an increased risk of failure versus Caucasians with this procedure. Larger studies are needed to further assess visual outcomes for this procedure in POAG and cataracts.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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