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Published on: January 26, 2018
Five-year follow-up with the PreserFlo MicroShunt for open-angle glaucoma
Lotte M J Scheres1, Stefani Kujovic-Aleksov2, Bjorn Winkens3
1University Eye Clinic Maastricht, Maastricht University Medical Center +, Maastricht, the Netherlands. lotte.scheres@mumc.nl.
Purpose:
To report on five-year results with the PreserFlo MicroShunt (MicroShunt) for the surgical treatment of open-angle glaucoma.
Patients And Methods:
Retrospective case series of consecutive patients who underwent a stand-alone MicroShunt implantation at the University Eye Clinic of Maastricht. If a patient underwent the procedure in both eyes, only the first eye was included in the analysis. MicroShunt implantation was augmented with 0.2 mg/ml mitomycin-C. The primary outcome was intraocular pressure (IOP) during follow-up. Furthermore, information on IOP-lowering medication use, success rates, reoperation rates, and postoperative complications was collected.
Results:
Sixty-six eyes were included for analyses. Diagnoses included primary open-angle glaucoma (88%) and pigmentary glaucoma (12%). The majority of patients had moderate or advanced glaucoma, based on the mean deviation of the visual field examination. Mean (95% - confidence interval) IOP dropped from 21.8 (20.8-22.8) at baseline to 13.2 (11.8-14.6) mmHg after 5 years (p < 0.001). Mean number of IOP-lowering medications was reduced from 2.5 (2.2-2.9) at baseline to 0.9 (0.5-1.2), 1.0 (0.7-1.4), and 1.1 (0.7-1.5) after three, four, and five years (all p < 0.001). Needling or surgical revision was performed in twelve eyes (18%). Nineteen eyes (29%) required further IOP-lowering surgery. Postoperative complications were usually mild and self-limiting and included early hypotony, shallow anterior chamber, and hyphaema.
Conclusions:
After five years, the MicroShunt was found to be a safe procedure, leading to a sustained reduction in mean IOP and number of IOP-lowering medications. However, almost one third of the eyes required further IOP-lowering interventions.
Insights
The PreserFlo MicroShunt safely lowers intraocular pressure for open-angle glaucoma over five years. While effective, nearly a third of patients required additional interventions to manage their glaucoma.
Area of Science:
- Ophthalmology
- Glaucoma Surgery
- Medical Devices
Background:
- Open-angle glaucoma is a leading cause of irreversible blindness worldwide.
- Surgical interventions are crucial for managing intraocular pressure (IOP) when medical therapy is insufficient.
- The PreserFlo MicroShunt is a device designed to reduce IOP in glaucoma patients.
Purpose of the Study:
- To evaluate the five-year efficacy and safety of the PreserFlo MicroShunt for treating open-angle glaucoma.
- To assess the long-term impact of MicroShunt implantation on intraocular pressure and medication use.
Main Methods:
- A retrospective case series of 66 eyes undergoing stand-alone MicroShunt implantation with mitomycin-C augmentation.
- Intraocular pressure (IOP), IOP-lowering medication use, success rates, reoperation rates, and complications were analyzed over five years.
- Only the first eye was included for patients with bilateral procedures.
Main Results:
- Mean IOP significantly decreased from 21.8 mmHg at baseline to 13.2 mmHg at five years (p < 0.001).
- The average number of IOP-lowering medications reduced from 2.5 at baseline to 0.9-1.1 postoperatively (p < 0.001).
- Twelve eyes (18%) required needling or revision, and 19 eyes (29%) needed further IOP-lowering surgery.
Conclusions:
- The PreserFlo MicroShunt demonstrates a safe and sustained reduction in IOP and medication use over five years.
- Despite its efficacy, a significant proportion of patients require additional surgical or medical interventions.
- The MicroShunt is a viable option for managing open-angle glaucoma, but patient selection and follow-up are critical.
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