Non-penetrating phaco-deep sclerectomy with SkGel implantation — long-term observations

Abstract

INTRODUCTION. The aim of this study is to present the efficacy and safety of non-penetrating phaco-deep sclerectomy (PDS) with implantation of an absorbable sodium hyaluronate implant (SkGel/Corneal).

MATERIALS AND METHODS. In a prospective case series study 219 procedures were performed on 176 subjects receiving PDS with SkGel implantation. Indications were uncontrolled primary-open angle glaucoma (POAG) and operable cataract. Data collected included best corrected visual acuity (BCVA), intraocular pressure (IOP), and number of hypotensive medications. Follow-up examinations were performed one and seven days after procedure, then one, three, and six months after, and thereafter every six months. Complete and qualified success (without and with hypotensive medications) was assessed for IOP ≤ 18 mm Hg and IOP ≤ 12 mm Hg.

RESULTS . The mean follow-up was 48.3 } 12.8 months. At 24 months, mean IOP decreased from 19.9 ± 5.0 mm Hg to 13.4 ± 3.1 mm Hg (P < 0.001) (31.8% reduction) and to 13.3 ± 2.7 mm Hg (P = 0.003) and after 60 months (33.2% reduction). At the 24-month follow-up, the average number of anti-glaucoma medications was reduced from 2.3 ± 0.8 to 0.62 ± 0.88 (p < 0.001). Complete and qualified success rates for IOP ≤ 18 mm Hg were 70.1% and 93.0%, respectively. Goniopuncture (23.8%), suturolysis (20.1%), and needling (18.3%) were performed. The most common complication was transient hypotony (36.07%).

CONCLUSIONS. PDS with SkGel leads to an effective decrease in IOP over a long-term follow-up. The profile of the complications indicates that it is a safe procedure.