Preserflo Microshunt

Summary of Evidence

Efficacy

Sustained reductions in mean IOP and medications were observed at 5 years post-PRESERFLO MicroShunt implantation. There were no reports of long-term sight-threatening AEs and a low rate of postoperative interventions.{Batlle JF, Corona A, Albuquerque R. Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study. J Glaucoma. 2021 Mar 1;30(3):281-286.}

Evidence

1. Background

2. Safety and efficacy

2.1 Comparative effectiveness

2.1.1 PRESERFLO alone

Clinical Trial

2021 Batlle et.al.

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2021
Clinical Trial

Sustained reductions in mean IOP and medications were observed at 5 years post-PRESERFLO MicroShunt implantation. There were no reports of long-term sight-threatening AEs and a low rate of postoperative interventions.{Batlle JF, Corona A, Albuquerque R. Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study. J Glaucoma. 2021 Mar 1;30(3):281-286.}

Retrospective case series of PRESERFLO Microshunt alone vs PRESERFLO Microshunt in combination with cataract surgery in patients with primary open angle glaucoma (21 eyes)
Findings:

Outcome	Baseline	Year 5
Mean IOP	23.8mmHg	12.4mmHg
Overall success		82.6%
Mean number of medications	2.4	0.8

2.1.2 PRESERFLO vs XEN

Clinical Trial

2021 Scheres et.al.

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2021
Clinical Trial

The Xen Gel Stent and PreserFlo MicroShunt implantations achieved comparable IOP-lowering and surgical success in POAG eyes at 2 years, with a similar high safety profile.{Scheres LMJ, Kujovic-Aleksov S, Ramdas WD, de Crom RMPC, Roelofs LCG, Berendschot TTJM, Webers CAB, Beckers HJM. XEN® Gel Stent compared to PRESERFLO™ MicroShunt implantation for primary open-angle glaucoma: two-year results. Acta Ophthalmol. 2021 May;99(3):e433-e440.}

Retrospective case series of XEN 45 gel stent or PRESERFLO Microshunt implantation in patients with primary open angle glaucoma (41 eyes of 31 patients)
Findings:
- Both devices achieved comparable results in IOP-lowering and surgical success, and with a similar high safety profile

Outcomes	Time period	XEN	PRESERFLO
IOP	Baseline	19.2mmHg	20.1mmHg
	24 months	13.8	12.1
Number of IOP lowering medications	Baseline	2.5	2.3
	24 months	0.9	1.1
Probability of qualified success	24 months	73%	79%

References

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