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One Year Results of the Preserflo MicroShunt Implantation for Refractory Glaucoma
Anna-Maria Seuthe1, Mariya Erokhina, Peter Szurman
1Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, Germany.
Prcis:
The Preserflo MicroShunt is an effective method to achieve a satisfying intraocular pressure (IOP) reduction in patients with complicated forms of glaucoma.
Purpose:
To evaluate the efficacy and safety of the Preserflo MicroShunt with mitomycin C in patients with complicated glaucoma.
Methods:
This prospective interventional study included all patients that underwent Preserflo MicroShunt Implantation between April 2019 and January 2021 to treat severe and therapy refractory glaucoma. The patients either suffered from primary open angle glaucoma with already failed incisional glaucoma surgery or presented severe forms of secondary glaucoma (eg, after penetrating keratoplasty or globe penetrating injury). Primary endpoint was the IOP-lowering effect and the success rate after 12 months. Secondary endpoint was the occurrence of intraoperative or postoperative complications. Complete success was defined as reaching the target IOP (>6 mm Hg and <14 mm Hg) without additional IOP-lowering medication whereas qualified success was attained with the same IOP target regardless of the medication.
Results:
A total of 40 eyes of 38 patients were enrolled. After 12 months 85.7% of the eyes achieved complete success with an average IOP of 10.5 ± 2.0 mm Hg, without the use of glaucoma eye drops. The average IOP reduction was 58.4% from baseline. In 5 cases (12.5%) failure occurred as revisional surgery was required.
Conclusion:
The Preserflo MicroShunt for refractory glaucoma cases achieved a high complete success rate without additional medication at 1 year. Revisional surgery was needed in some cases and long-term studies are needed.
Insights
The Preserflo MicroShunt effectively lowers intraocular pressure in complex glaucoma patients. High success rates were observed at 12 months, reducing the need for medication.
Area of Science:
- Ophthalmology
- Glaucoma Surgery
- Medical Devices
Background:
- Complicated glaucoma requires effective intraocular pressure (IOP) reduction.
- The Preserflo MicroShunt is a potential treatment for refractory glaucoma.
Purpose of the Study:
- To evaluate the efficacy and safety of the Preserflo MicroShunt with mitomycin C.
- To assess IOP reduction in patients with complicated glaucoma.
Main Methods:
- Prospective interventional study of 40 eyes with severe, therapy-refractory glaucoma.
- Preserflo MicroShunt Implantation performed between April 2019 and January 2021.
- Primary endpoint: IOP-lowering effect and success rate at 12 months; Secondary endpoint: complications.
Main Results:
- 85.7% of eyes achieved complete success (IOP 10.5 ± 2.0 mm Hg) without medication at 12 months.
- Average IOP reduction was 58.4% from baseline.
- 12.5% of cases required revisional surgery.
Conclusions:
- Preserflo MicroShunt demonstrates high complete success rates for refractory glaucoma at 1 year.
- The device effectively reduces IOP without additional medication.
- Further long-term studies are warranted.
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