Abstract
Purpose :
To evaluate outcomes with the XEN45 gel stent via an Ab Externo approach
Methods :
Retrospective chart review. IOPs and numbers of IOP lowering medicines (NMed) were censored following reoperation. High baseline IOP defined as preop IOP ≥ 18mmHg. Postop hypotony defined as 2 or more visits with IOP ≤5mmHg at/after 1 month. Failure in the high IOP group defined as reoperation to control IOP or two consecutive follow up visits at/after month 1 with IOP >21 or not reduced by 20%; high IOP failure in the low baseline IOP group defined as reoperation to control IOP or two consecutive follow up visits at/after month 1 with IOP > than baseline IOP
Results :
60 eyes of 57 patients with ≥3 months follow up were analyzed. Follow up ranged from 3.3 to 8.1 months (median=5.9 months) with 43 (72%) eyes contributing a 6 month visit. Age ranged from 34 to 89 years(mean=73.9) and 32 (56%) were female. 46 (77%) eyes had POAG. Preoperative IOP averaged 19.4 (SD=6.6, range = 9, 48) mmHg and NMed averaged 3.5 (SD=1.4, range = 1, 8). 34 (57%) of eyes had high preoperative IOP.
7 eyes underwent reoperation for IOP control. The cumulative 6 month Kaplan-Meir reoperation rate was 18% in the high IOP group and 4% in the low IOP group. One eye in the high IOP group had hypotony. Failure to control IOP was observed in 8 (23%) and 7 (27%) of eyes in the high and low baseline IOP groups, respectively. 10 (29%) and 7 (27%) of eyes required needling in the high and low baseline IOP groups, respectively. 3 (18%) of the needled eyes required a reoperation to control pressure.
Average IOP was lowered 5.2mmHg, 3.7mmHg, and 6.1mmHg at postop months 1, 3, and 6, respectively (all p ≤ 0.001). At the 1, 3, and 6 month visits, average IOP reductions ranged from 8.0 to 11.0 mmHg in the high baseline IOP group compared to reductions ranging from -0.5 to 1.7mmHg in the low baseline IOP group (all p<0.001).
Average numbers of IOP lowering meds required was lowered by 2.9, 2.3, and 2.2 at postop months 1, 3, and 6, respectively (all p<0.001).
Complications noted at M01 included hyphema with IOP spike (n=2) and blockage of implant (n=1), at M03 included shallow AC (n=7) and hypotony (n=1) and at M06 included IOP spike (n=1) and blockage of tip (n=1).
Conclusions :
The gel stent, when performed via an ab externo approach appears to be safe and effective. The results are similar to the previously published results for ab interno implantation
This is a 2020 ARVO Annual Meeting abstract.