Abstract
PurposeTo 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).MethodsFifty 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.ResultsMean 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.ConclusionsBoth 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.
Highlights
Glaucoma is still responsible for irreversible blindness globally [1]
The method itself has been rigorously improved over the years [6], its use among surgeons is declining in favor of newer micro invasive glaucoma surgery (MIGS) devices [7]
Its true benefit in glaucoma surgery is still being debated [16, 17], Ologen collagen matrix (OCM) is currently being widely utilized extending beyond glaucoma surgery [18] to other ocular pathologies, for instance in pterygium excision where it modulates the wound healing of the conjunctiva and serves as an inhibitor of recurrence [19]
Summary
Glaucoma is still responsible for irreversible blindness globally [1]. Patient numbers around the world are rising and projected to reach 111.8 million soon [2]. Surgeons appear to be favoring such alternatives due to their superior safety and efficacy profiles [8] These glaucoma implants have been introduced as a minimally invasive surgical option to prevent further glaucoma deterioration. These devices provide an outflow pathway of the aqueous humor from the anterior chamber of the eye into the posterior subtenonal space, and reduce IOP by mimicking the mechanism of trabeculectomy, while simultaneously conferring a standardized IOP outcome and an enhanced safety profile [9,10,11]. If the OCM implantation reduces the fibrotic reaction in the bleb area either through its properties or by acting as a barrier or spacer, a reduction of revision surgery, needling interventions and additional use of antimetabolites or chemotherapeutical agents such as 5fluorouracil (5-FU) should be reported
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