Purpose: PRESERFLO^Ⓡ MicroShunt is a minimally invasive glaucoma surgery (MIGS) device that has currently been clinically approved in Europe. It enables filtration surgery without trabeculectomy or peripheral iridectomy. Here we report the postoperative 1-year outcomes of this surgery as a pilot study in Japanese patients.
Subjects and methods: The study evaluated nine eyes in eight patients who were evaluated to be eligible to undergo filtration surgery due to primary open angle glaucoma that was being treated with eye drops. This was a single-facility prospective study, wherein surgery was performed by two physicians. Cataract surgery was simultaneously performed on one eye. Changes in intraocular pressure, complications, and postoperative treatment were investigated preoperatively and at 1 day, 1 week, and 1, 3, 6, 9, and 12 months postoperatively.
Results: Preoperative intraocular pressure and medication score (mean±standard deviation) were 18.1±3.4 mmHg and 3.6±0.5, respectively, for all the nine eyes. After excluding one dropout case, these results were 17.9±3.5 mmHg and 3.5±0.5, respectively, for eight eyes. The intraocular pressure and medication score decreased significantly at all postoperative time points compared with that observed preoperatively, regardless of whether the dropout case was excluded or not. At 1 year postoperatively, the intraocular pressure and medication score were 13.8±3.0 mmHg and 1.6±1.4, respectively (n=8). The only complication observed was transient hyphema in one eye early after surgery. No significant postoperative decreases in corneal endothelium cell count or visual acuity were observed. Trabeculectomy was performed on one eye at 5 months postoperatively. Postoperative needling was required once for two eyes and twice for two eyes.
Conclusion: The results of observing the 1-year outcomes of MicroShunt filtration surgery for the eyes of Japanese patients with primary open angle glaucoma indicated that surgery with this device was a highly safe and effective technique for performing glaucoma filtration surgery.
Nippon Ganka Gakkai Zasshi (J Jpn Ophthalmol Soc) 124: 705-712, 2020.