Sato Tomoki, Kawaji Takahiro, Hirata Akira, Mizoguchi Takanori
Sato Eye and Internal Medicine Clinic, Kumamoto, Japan.
Hayashi Eye Hospital, Fukuoka, Japan.
BMJ Open Ophthalmol. 2018 Oct 25;3(1):e000159. doi: 10.1136/bmjophth-2018-000159. eCollection 2018.
We performed a pilot trial to evaluate the 24-month safety and efficacy of 360-degree suture trabeculotomy ab interno with phacoemulsification used to treat mild to moderate open-angle glaucoma coexisting with cataract.
We randomly assigned 18 eyes with open-angle glaucoma and coexisting cataract to undergo 360-degree suture trabeculotomy ab interno with phacoemulsification (combined) or phacoemulsification alone (control) (1:1 ratio) and followed up patients for 24 months. Main outcome measures were mean postoperative intraocular pressure (IOP) and success probabilities based on Kaplan-Meier life table analyses. Surgical success was defined as follows: criterion A: IOP value ≥6 mm Hg and ≤15 mm Hg, with ≥20 % reduction without medication; criterion B: IOP value ≥6 mm Hg and ≤12 mm Hg, with ≥30% reduction without medication. Secondary outcome measures included the number of medications, complications and best-corrected visual acuity.
Mean IOP values (number of medications), which were 18.4 mm Hg (0.9) and 17.1 mm Hg (1.3) at baseline, showed significant reductions to 11.8 mm Hg (1.0) and 14.6 mm Hg (1.5) at 24 months postoperatively in the combined and control groups, respectively (p=0.0003 and 0.0192, respectively). Success rates for criterion A in the combined and control groups were 77.8% and 11.1%, respectively (p=0.0110) and those for criterion B in the combined and control groups were 46.7% and 0%, respectively (p=0.0036). Both groups had a similar overall occurrence of postoperative complications.
Using 360-degree suture trabeculotomy ab interno with phacoemulsification appeared to be a more beneficial option for mild to moderate open-angle glaucoma with coexisting cataract than phacoemulsification alone.
UMIN000021170, date of registration: 2016/03/01.
我们进行了一项试点试验,以评估内路360度缝线小梁切开术联合白内障超声乳化术治疗轻度至中度开角型青光眼合并白内障的24个月安全性和有效性。
我们将18例开角型青光眼合并白内障患者随机分为两组,分别接受内路360度缝线小梁切开术联合白内障超声乳化术(联合组)或单纯白内障超声乳化术(对照组)(1:1比例),并对患者进行24个月的随访。主要观察指标为术后平均眼压(IOP)以及基于Kaplan-Meier生存表分析的成功概率。手术成功的定义如下:标准A:眼压值≥6 mmHg且≤15 mmHg,无需药物治疗眼压降低≥20%;标准B:眼压值≥6 mmHg且≤12 mmHg,无需药物治疗眼压降低≥30%。次要观察指标包括用药数量、并发症及最佳矫正视力。
联合组和对照组的基线平均眼压值(用药数量)分别为18.4 mmHg(0.9)和17.1 mmHg(1.3),术后24个月时分别显著降至11.8 mmHg(1.0)和14.6 mmHg(1.5)(p分别为0.0003和0.0192)。联合组和对照组标准A的成功率分别为77.8%和11.1%(p = 0.0110),标准B的成功率分别为46.7%和0%(p = 0.0036)。两组术后并发症的总体发生率相似。
对于轻度至中度开角型青光眼合并白内障患者,内路360度缝线小梁切开术联合白内障超声乳化术似乎比单纯白内障超声乳化术更有益。
UMIN000021170,注册日期:2016/03/01。