Preliminary results of Preserflo Microshunt versus Preserflo Microshunt and Ologen implantation

Abstract

Purpose

To report preliminary 6-month results on the use of the Preserflo Microshunt implant with and without Ologen in 50 pseudophakic eyes with moderate to advanced primary open-angle glaucoma (POAG).

Methods

Fifty pseudophakic eyes underwent ab externo Preserflo Microshunt implantation. Data was gathered retrospectively and two groups were then created, group A with application of MMC 0.2 mg/ml and group B with MMC 0.2 mg/ml and Ologen collagen matrix (OCM) implantation. Absolute success was regarded as the percentage of eyes achieving: a) 5 ≤ intraocular pressure (IOP) ≤ 13 mmHg, b) 5 ≤ IOP ≤ 16 mmHg, and c) 5 ≤ IOP ≤ 21 mmHg without additional medication or surgery and qualified success was regarded as the percentage of eyes achieving a) IOP ≤ 13 mmHg, b) IOP ≤ 16 mmHg, and c) IOP ≤ 21 mmHg with or without medication. Evaluation was performed using a log-rank Kaplan-Meier test. A scatterplot analysis presented the treatment effect data of all eyes with a minimum of 20% IOP reduction per case. Failure was defined as requiring additional surgery, IOP greater than 21 mmHg with or without medication and failure to reach 20% IOP reduction.

Results

Mean postoperative IOP was significantly lower in both groups. IOP decreased by 49.06% in group A and by 53.01% in group B at 6 months (P < 0.88), respectively. Medication use was lower in both groups (Wilcoxon test, P < 0.001). The absolute and qualified success rates were not statistically significant between the groups (all P > 0.05). Cumulative IOP results per case were not statistically different in group A compared with group B. One revision surgery in group A (4% failure rate) and three in group B (12% failure rate) were performed.

Conclusions

Both groups showed equal results in terms of cumulative and mean IOP reduction, medication reduction as well as in absolute and qualified success rates. No significant difference was found in any parameters tested between Preserflo Microshunt with MMC 0.2 mg/ml and with or without OCM implantation at 6 months. Long-term follow-up is required to further evaluate this data.