ESCRS - FP16.01 - Sustained 7-Year Glaucoma Control After Second-Generation Trabecular Micro-Bypass With Or Without Cataract Surgery

Sustained 7-Year Glaucoma Control After Second-Generation Trabecular Micro-Bypass With Or Without Cataract Surgery

Published 2023 - 41st Congress of the ESCRS

Reference: FP16.01 | Type: Free paper | DOI: 10.82333/3mba-gx17

Authors: Fritz Hengerer* 1 , Ina Conrad-Hengerer 2 , Gerd U Auffarth 2

1Ophthalmology,Buergerhospital,Frankfurt,Germany, 2Ophthalmology,University Eye Hospital ,Heidelberg,Germany

Purpose

Given Germany’s early adoption of 2nd-generation trabecular micro-bypass (iStent inject), German datasets provide some of the longest-term outcomes in the world to-date.  The current study evaluated 7-year (7Y) effectiveness & safety of iStent inject implantation w/ or w/o cataract surgery (Combined/Comb or Standalone/SA subgroups, respectively).

Setting

Large academic ophthalmology center in Heidelberg, Germany.

Methods

This prospective, non-randomized, unmasked, longitudinal study included 125 consecutive iStent inject cases of a single surgeon at a large German academic hospital.  Patients had considerable preoperative (preop) disease burden, with mean intraocular pressure (IOP) of 23.5 mmHg, 85% of eyes on ≥2 medications (meds), and 38% of eyes with prior glaucoma surgery. IOP, meds, adverse events, and secondary surgeries were assessed through 7Y in All Eyes and in Comb (n=81) and SA (n=44) subgroups. The completion of both types of procedures by the same surgeon in the same setting enables validation of long-term stent performance independent from cataract extraction. 

Results

Preop mean IOP in All Eyes was 23.5±6.2mmHg on 2.68±1.02 mean meds, reducing to 14.1±1.4mmHg on 1.09±0.66 meds at 7Y (40% and 59% reductions, respectively; both p<0.001).  15% of eyes were on 0-1 med preop, and this rose to 77% at 7Y postop.  In Comb eyes, mean IOP decreased by 38% (22.6 to 13.9mmHg, p<0.001) and meds by 58% (2.52 to 1.06, p<0.001).  In SA eyes, mean IOP reduced by 43% (25.3 to 14.3mmHg, p<0.001) and meds by 62% (2.98 to 1.13, p<0.001).  At last follow-up, 100% of eyes had the same or lower IOP vs preop, and 100% maintained or reduced meds vs preop. There were no intraoperative complications and no filtration surgeries over 7 years of follow-up.

Conclusions

iStent inject implantation with or without phacoemulsification produced significant and durable 7-year reductions in IOP (~10-mmHg reduction) and meds (~2-med reduction) in this prospective cohort of patients with relatively high preoperative disease burden.  Comb and SA cases had similarly favorable effectiveness and safety.