Comparison of ExPress Mini-Device Implantation Alone or Combined with Phacoemulsification for the Treatment of Open-Angle Glaucoma

Abstract

We propose comparative assessment of the effectiveness of two surgical methods for the treatment of open-angle glaucoma: (1) ExPress mini-device implantation combined with phacoemulsification and (2) ExPress mini-device implantation alone. In this prospective study, 81 patients (88 phakic eyes) with uncontrolled open-angle glaucoma enrolled for surgery. They were assigned two groups, those with coexisting cataracts (46 eyes; P-ExPress group) and those with glaucoma alone (42 eyes; ExPress group). The follow-up period was 12.9 ± 0.4 months in P-ExPress and 12.2 ± 0.6 months in ExPress group. In both groups the following parameters were measured: best corrected visual acuity (BCVA), intraocular pressure (IOP), number of complications and necessary postoperative interventions, and number of glaucoma medications. The IOP at the end of follow-up was similar in both groups (18.8 ± 5.9 versus 18.1 ± 4.8 mmHg; P = 0.814). There were no statistical differences in the average number of glaucoma medications between ExPress and P-ExPress groups (0.9 ± 1.65 versus 1.3 ± 1.7; P = 0.419) as well as in the number of postoperative complications (26 versus 21%; P = 0.179 in the P-ExPress and ExPress groups, resp.). Both methods are safe and effective for the surgical treatment of open-angle glaucoma. Coexistence of cataracts does not constitute a compelling contraindication for combined surgery.

Mini-canaloplasty as a modified technique for the surgical treatment of open-angle glaucoma

“…The project is compliant with the principles of the International Helsinki Federation for Human Rights and is aligned with the Good Clinical Practice for Trials on Medicinal Products developed by the European Union. It has been approved by the Bioethics Commission of the Military Institute of Medicine in Warsaw as it was in the previous studies 24 – 26 .…”

“…The protocol of the examination was similar to those we previously employed 24 – 26 . The indications for the procedure were the same as those of the conventional method: patients with primary open-angle glaucoma, pseudoexfoliative glaucoma, and normal tension glaucoma and in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment (both topical and systemic).…”

“…Written informed consent for performing this modified procedure was obtained from all patients after they had been informed of the nature of the procedure and other surgical alternatives. Exclusion criteria were as follows: consent not provided to participate in the study, prior surgical and laser procedures in the area of the eye, narrow or closed-angle glaucoma, post-inflammatory or post-traumatic secondary glaucoma, chronic illness of the cornea or optic nerve, advanced macular degeneration, active inflammatory process, pregnancy, and systemic steroid therapy 24 – 26 .…”

“…Before surgical treatment, all patients underwent a basic examination, which included determination of the IOP, uncorrected distance visual acuity (UDVA), CDVA, and ophthalmologic examination of the anterior and posterior segments of the eye. If a patient had a coexisting cataract, then the intraocular lens was measured in order to have combined phaco-canaloplasty procedure 24 – 26 . In three cases where a concomitant cataract was found, combined canaloplasty and phacoemulsification procedure was performed.…”

“…During the follow-up visits, the IOP was measured using the Goldmann applanation tonometer, whereas the CDVA was measured using a logarithm of the minimal angle of resolution (logMAR) + notification. All IOP measurements were taken between 8 and 10 a.m. 24 – 26 . The anterior chamber and retina were assessed.…”