НЕПРОНИКАЮЩАЯ ГЛУБОКАЯ СКЛЕРЭКТОМИЯ И ИМПЛАНТАЦИЯ ДРЕНАЖА EX-PRESS R-50 В ХИРУРГИЧЕСКОМ ЛЕЧЕНИИ ГЛАУКОМЫ

Abstract

PURPOSE: Analysis of the mediumand long-term results of the mini-shunt Ex-Press implantation in glaucoma surgical treatment. METHODS: Non-penetrating deep sclerectomy with the mini-shunt Ex-PRESS R-50 implantation was performed in 198 eyes of 177 patients with uncontrolled and/or refractory glaucoma between 2011 and 2014. Exclusion criteria for patients: signs of neovascularisation, close-angle or congenital glaucoma, previous ophthalmologic surgeries during the last 6 months, the need for simultaneous combined cataract and glaucoma surgery. The study included 161 patients (176 eyes). A review of the patients’ anamnesis revealed a history of previous glaucoma surgical procedures in 126 (77.6%) patients, cataract phacoemulsification with IOL implantation in 108 (67%) patients and vitrectomy in 43 (26.7%) cases. All surgical interventions were undertaken within a period of more than 6 months before the present study. A standard ophthalmologic examination was performed in all patients prior to surgery and on days 1 and 7, as well as 1, 2, 3, 6, 12, 18, 24 and 36 months after the drainage implantation. In a number of patients, examinations were also performed 48 (n=44, 27.3%) and 60 (n=21, 13%) months after the operation. In addition, patients were divided into group I («phakic» glaucoma, n=53; 32.9%) and group II (pseudophakic glaucoma, n=108; 78.3%) RESULTS: The mean follow-up period was 43.7±2.9 months. The mean age of patients at the time of surgery was 72.4 ± 9.6 years, with 63 (39.1%) male and 98 (60.9%) female patients. IOP decrease compared to preoperative values of 32.3±8.7 mmHg amounted to 6.2±7.7 mm Hg after 1 week, 11.9±5.8 mm Hg after 1 month, 12.5±4.0 mm Hg after 2 months, 12.7±4.8 mm Hg after 3 months, 12.1±4.5 mm Hg after 6 months, 11.7±4.2 mm Hg after 12 months, 12.9±5.1 mm Hg 18 months after surgery. At the follow-up period of 24 months, the IOP decreased to 15.3±6.6 mm Hg, and at follow-ups of 36 months to 17.5±6.8 mm Hg (45.8%). In 44 (27.3%) patients 48 months later, the IOP level exceeded the compensation level with average values of 22.4±8.0 mm Hg. In 60 months after the operation 21 (13%) patients had a mean IOP level of 26.1±8.2 mm Hg. A statistically insignificant change in BCVA from 0.61±0.25 in the preoperative period to 0.57±0.31 during the last examination was observed (p>0.1). There was a significant decrease in the number of glaucoma instillations with the average numbers of 0.55±1.1 and 0.89±1.2 24 and 36 months after the surgery respectively, compared to 2.7±0.9 prior to the surgery (p=0.002 and p=0.01). In all the investigated cases, a daily massage of the filtration zone was performed during the postoperative period. In 94 (58.4%) patients, the IAG laser procedure was performed on the shunt at various postoperative times. Postoperative complications included a transient hypotension in the early (10-14 days) postoperative period, Seidel’s symptom and bleb encapsulation, which required additional intervention. At the maximum follow-up period of 36 months, somewhat better results were obtained in group II (mean IOP 15.9±4.2 mm Hg vs. 17.3±4.4 mm Hg in group I, p>0.1). Similar differences were obtained for the number of glaucoma drugs taken (0.81±0.9 in group II against 0.97±1.1 in group I, p>0.1). Larger differences were obtained for BCVA during the long-term follow-up period (0.62±0.26 in group II versus 0.38±0.21 in group I, 0.05<p<0.1). CONCLUSION: Ex-PRESS mini-shunt implantation is indicated in patients with refractory glaucoma when with previous interventions and maximum antihypertention regimen proved insufficient to compensate intraocular pressure level. Relative simplicity of the implantation technique, a small percentage of complications and a high efficiency in the medium term observation period make it possible to recommend the use of this device for wide ophthalmic surgical practice. Optimal results are possible with the implantation of a mini-shunt under the superficial scleral flap and a special mode of postoperative management of the patient, which allows to maintain the functioning of the shunt and to provide a tolerant intraocular pressure. Implantation of the mini-shunt Ex-PRESS R-50 in patients with pseudophakia results in slightly better but statistically insignificant functional results, however, due to the reduction in the effect in long-term (up to 5 years) follow-up, this surgical intervention is not an operation of first choice for this group of patients.