Abstract
Purpose :
Minimally invasive bleb surgery has gained importance in glaucoma therapy in recent years. The PRESERFLO® MicroShunt (PMS) is a novel implant draining aqueous humour into the subconjunctival space and thereby lowering intraocular pressure (IOP). However, the long-term success, safety profile and impact on endothelial cell density remain to be investigated.
Methods :
In this prospective observational study, 73 eyes of 64 glaucoma patients (mean age ± SD: 67.0 ± 15.0 years) receiving a PMS were included. IOP, endothelial cell density (ECD), best corrected visual acuity (BCVA) and number of IOP lowering medications were analyzed preoperatively and at 3, 6, 9, 12, 18 and 24 months postoperatively. Rates of complete and qualified success were calculated by Kaplan-Meier analysis. Complete success indicated an IOP reduction of ≥ 20% and reaching a target IOP of ≤ 18, ≤ 15 or ≤ 12 mmHg without antiglaucoma medication, while qualified success was labelled if these parameters were achieved with or without medication. Also, complications and surgical bleb revision rates were assessed.
Results :
IOP was reduced significantly from 28.46 ± 0.05 mmHg to 12.37 ± 0.07 mmHg after 24 months (p < 0.001). The number of IOP lowering medication decreased significantly in the operated eyes from 3.2 ± 0.9 preoperatively to 0.2 ± 0.8 (p < 0.001). BCVA was not significantly altered after 24 months (p > 0.05). Complete and qualified success with a target IOP ≤ 15 mmHg was achieved in 28.8% and 46.5% of eyes, respectively, after 24 months. ECD showed no significant decline over the 24-month follow-up period (p > 0.05). A needling was necessary at least once in 27 (36.9%) of all eyes. An incisional bleb revision was performed in 18 eyes (24.7%). Forty-three eyes (58.9%) did not require any bleb revision surgery within 24 months.
Conclusions :
PMS implantation is a safe and effective therapeutic option in open-angle glaucoma and does not seem to harm the corneal endothelial cells within two years after surgery. Longer observation periods will be examined in following studies.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.