scholarly journals PreserFlo MicroShunt® exposure: a case series

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Roxane Bunod ◽  
Mathieu Robin ◽  
Juliette Buffault ◽  
Chafik Keilani ◽  
Antoine Labbé ◽  
...  

Abstract Background PreserFlo® MicroShunt (PM) (also known as InnFocus® MicroShunt) is a subconjunctival stent implanted ab externo via a minimally invasive surgical procedure. The current indication is progressive, mild to moderate, open angle glaucoma uncontrolled on topical medications. According to the literature, adverse events are rare, mild and transient. Case presentation Two cases of stand-alone PreserFlo MicroShunt® implantation in patients with uncontrolled open-angle glaucoma are reported. Exposure occurred 7 days and 3 months respectively after implantation. These cases shared common features including preexisting blepharitis and the lack of a Tenon’s flap. In both cases, removal of the device was required after several attempts at repair. Conclusions PreserFlo MicroShunt® exposure is a potentially vision-threatening complication because of the risk of endophthalmitis. Potential risk factors include the absence of a Tenon’s flap and pre-existing ocular surface inflammation. Ocular surface inflammation should be detected and treated prior to PM implantation. If a deficiency in Tenon’s capsule is noted intraoperatively, close monitoring should be performed because of the higher risk of PM exposure.

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Anna Zaleska-Żmijewska ◽  
Ewa Strzemecka ◽  
Zbigniew M. Wawrzyniak ◽  
Jacek P. Szaflik

Purpose. Objective assessment of dry eye disease (DED) severity and ocular inflammation using the InflammaDry® test for extracellular matrix metalloproteinase-9 (MMP-9) and the impact of antiglaucoma eye drops in people with primary open-angle glaucoma (POAG). Methods. Overall, 90 adults (180 eyes) were included: 60 had been diagnosed with POAG and were treated with prostaglandin analogue monotherapy and 30 were suspected of having POAG but did not receive any treatment (control group). Of those treated with prostaglandin eye drops, 30 received a preservative-free formulation (tafluprost) and 30 were treated with a formulation containing the preservative benzalkonium chloride (BAK) (latanoprost). Measurement of extracellular MMP-9 levels (InflammaDry test) provided a marker for ocular surface inflammation. Further assessments of disease severity and inflammation comprised Goldmann applanation tonometry for intraocular pressure (IOP), Schirmer’s test with anesthesia, ocular surface staining with unpreserved fluorescein (Oxford scale index), tear breakup time (TBUT), McMonnies questionnaire, and the Ocular Surface Disease index (OSDI). Results. Clinically significant MMP-9 levels (>40 ng/mL) were detected in tear film from 46.7% of subjects treated with BAK-containing medication. In contrast, only 16.7% of subjects treated with preservative-free medication or untreated individuals demonstrated similar MMP-9 levels. This difference was statistically significant (p<0.05). MMP-9 results correlated with other indicators of inflammation and disease severity. BAK-containing medication was associated with rapid TBUT (<5 seconds) in 50% of cases, while only 10% of untreated subjects and individuals using preservative-free medication demonstrated comparable TBUT results. Conclusion. Measurement of ocular surface MMP-9 level provides a useful marker for inflammation and DED in POAG. Use of a preservative-free topical prostaglandin formulation results in lower levels of ocular inflammation, compared with BAK-containing medication.


2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Daisuke Shiba ◽  
Shingo Hosoda ◽  
Saori Yaguchi ◽  
Naoki Ozeki ◽  
Kenya Yuki ◽  
...  

Purpose. To evaluate efficacy and safety of a trabecular micro-bypass stent system when used as the sole procedure in Japanese patients with medically uncontrolled primary open-angle glaucoma (POAG). Design. Prospective nonrandomized interventional pilot study. Methods. Ten eyes of 10 Japanese patients with medically uncontrolled POAG taking three ocular hypotensive medications were treated using only the implantation of two iStent trabecular micro-bypass stents. Each patient continued to take the same ocular hypotensive medications used preoperatively throughout the study. Intraocular pressure (IOP) and endothelial cell density (ECD) were determined at baseline and at 1, 3, and 6 months postoperatively. Best-corrected visual acuity (BCVA) was measured at baseline and 6 months after surgery. Results. Mean IOP was 22.0±3.0 mmHg at baseline and 16.9±3.6 mmHg at 6 months, which represented a mean reduction of 5.1 mmHg or 23.2%. No significant changes were observed in the ECD and BCVA. Complications that occurred during the early postoperative period included hyphema, peripheral anterior synechiae, and occlusion of the stent by the iris. Conclusion. Implantation of two trabecular micro-bypass stents as the sole procedure in Japanese POAG patients effectively reduced IOP and exhibited a favorable safety profile. Clinical Trials Registration number is UMIN000004002.


2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  

Purpose The SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE). Methods In this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis®) or its vehicle for 6 months, followed by 6-month open-label, once-daily CsA CE (CsA CE/CsA CE and vehicle/CsA CE groups). Results A total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA. Conclusions In this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.


2010 ◽  
Vol 88 ◽  
pp. 0-0
Author(s):  
A DENOYER ◽  
D GODEFROY ◽  
J FRUGIER ◽  
F BAUDOUIN ◽  
W ROSTèNE ◽  
...  

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