Abstract
To assess the effectiveness and safety of the Preserflo Microshunt (PMS) implantation combined with cataract surgery in open-angle glaucoma (OAG) patients. Retrospective, open-label study conducted on insufficiently controlled OAG patients, who underwent a PMS implant procedure with mitomycin-C 0.2%, either alone or in combination with cataract surgery, and were followed for at least 12 months. Success was defined as an intraocular pressure (IOP) ≤ 18 mmHg and a reduction of at least 20% without (complete) or with (qualified) hypotensive medication. Fifty-eight eyes were included in the study, 35 eyes underwent PMS alone and 23 underwent PMS + Phaco. In the overall study sample, mean IOP was significantly lowered from 21.5 ± 3.3 mmHg at baseline to 14.6 ± 3.5 mmHg at month 12 (p < 0.0001). The IOP was significantly reduced in both groups; p < 0.0001 each, respectively. Ocular hypotensive medication was significantly reduced (p < 0.0001) in both groups. No significant differences were observed in IOP lowering or medication reduction between groups. At month 12, 62.1% eyes were considered as complete success and 82.8% eyes as qualified success. The most common adverse events were device close-to-endothelium, conjunctival fibrosis, and wound leakage. PMS, either alone or in combination with phacoemulsification, may be considered as a valuable option for treating OAG patients.
Highlights
Glaucoma is a chronic and progressive optic neuropathy that, in advance stages, has a significant impact on patient’s quality of life[1,2]
Preserflo Microshunt (PMS, Santen Inc., Miami, FL; formerly known as the InnFocus Microshunt) is a new ab-externo and subconjunctival minimally invasive glaucoma surgery (MIGS) device designed for treating patients with early to advanced open-angle glaucoma (OAG)
The purpose of the current paper is to evaluate the efficacy and safety of PMS implantation combined with cataract surgery in patients with open-angle glaucoma
Summary
Glaucoma is a chronic and progressive optic neuropathy that, in advance stages, has a significant impact on patient’s quality of life[1,2]. Despite trabeculectomy and drainage devices have shown to be effective for lowering IOP4, they may be associated with different complications, some of them severe, that may lead to visual impairment[5]. This has led to the search for safer surgical alternatives, but with similar efficacy. Under the term minimally invasive glaucoma surgery (MIGS) different devices and surgical procedures, which modulate aqueous humor outflow facility via one of several routes, have e merged[6]. Preserflo Microshunt (PMS, Santen Inc., Miami, FL; formerly known as the InnFocus Microshunt) is a new ab-externo and subconjunctival MIGS device designed for treating patients with early to advanced open-angle glaucoma (OAG). SIBS has been associated with minimal inflammation or encapsulation, especially when compared with other implant materials, such as silicone rubber[9]
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