Katz L Jay, Erb Carl, Carceller Guillamet Amadeu, Fea Antonio M, Voskanyan Lilit, Wells Jeffrey M, Giamporcaro Jane Ellen
Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA.
Eye Clinic Wittenbergplatz, Berlin, Germany.
Clin Ophthalmol. 2015 Dec 11;9:2313-20. doi: 10.2147/OPTH.S96695. eCollection 2015.
To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG) not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively.
Subjects with medicated intraocular pressure (IOP) 18-30 mmHg and postmedication-washout baseline IOP 22-38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg.
A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ≥20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ≤18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ≤15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001) with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96-2.73) for three-stent vs two-stent groups and 1.73 mmHg (95% confidence interval 0.83-2.64) for two-stent vs one-stent groups. Adverse events through 18 months were limited to cataract progression with best-corrected visual acuity loss and subsequent cataract surgery.
In this series, implantation of each additional stent resulted in significantly greater IOP reduction with reduced medication use. Titratability of stents as a sole procedure was shown to be effective and safe, with sustained effect through 18 months postoperatively in OAG not controlled with medication.
评估在使用降眼压药物治疗仍无法控制的原发性开角型青光眼（OAG）患者眼中植入一、二或三个小梁微旁路支架的安全性和有效性。共119名受试者术后随访18个月。
将药物治疗后眼压（IOP）为18 - 30 mmHg且药物洗脱后基线眼压为22 - 38 mmHg的受试者随机分为植入一、二或三个支架组。若术后眼压超过18 mmHg，则使用降眼压药物。
共38名受试者植入一个支架，41名受试者植入两个支架，40名受试者植入三个支架。分别有89.2%、90.2%和92.1%的植入一个、两个和三个支架的眼睛在第12个月时眼压降低≥20%（未使用降眼压药物）相对于基线未用药眼压，且第12个月未用药眼压≤18 mmHg。此外，三个组中分别有64.9%、85.4%和92.1%的受试者未用药眼压≤15 mmHg。在18个月的随访期内，7名植入一个支架的受试者、4名植入两个支架的受试者和3名植入三个支架的受试者需要使用药物。在18个月时，植入一个支架的受试者平均未用药眼压为15.9±0.9 mmHg，植入两个支架的受试者为14.1±1.0 mmHg，植入三个支架的受试者为12.2±1.1 mmHg。每增加植入一个支架，第18个月时眼压降低幅度显著更大（P<0.001），三个支架组与两个支架组相比平均降低幅度差异为1.84 mmHg（95%置信区间0.96 - 2.73），两个支架组与一个支架组相比平均降低幅度差异为1.73 mmHg（95%置信区间0.83 - 2.64）。至18个月时的不良事件仅限于白内障进展伴最佳矫正视力丧失及随后的白内障手术。
在本系列研究中，每增加植入一个支架可使眼压降低幅度显著增大且药物使用减少。作为单一手术方式，支架的可滴定性被证明是有效且安全的，在药物治疗无法控制的OAG患者中术后18个月内效果持续存在。
