Military Health Service Institute, Ophthalmology Department, Warsaw, Poland.
Curr Med Res Opin. 2010 May;26(5):1131-7. doi: 10.1185/03007991003719428.
To compare the efficacy and safety of phacoemulsification - deep sclerectomy (PDS) with absorbable SK-gel or non-absorbable T-flux implantation.
The study involved eyes after PDS with SK-gel (32 eyes) and T-flux (20 eyes). Primary open angle glaucoma without satisfying intraocular pressure (IOP) control (> or =21 mmHg) despite maximally tolerated medication or with progression of the visual field and cataract was the indication for surgery. For statistical analyses, the Mann-Whitney U test, Student's t-test, pair sequence Wilcoxon test, and analysis of variance were used. Survival analysis was done using the Kaplan-Meier method.
The best corrected visual acuity (BCVA), IOP, anterior and posterior segments of the eye, and number of antiglaucoma medications were examined. Follow-up examinations were performed on days 1 and 7, and at 1, 3, 6, 12, 18 and 24 months. A complete success rate was defined as IOP < or =18 mmHg without and qualified success as IOP < or =18 mmHg with or without antiglaucoma medications.
After a 24-month follow-up, mean IOP decreased in the SK-gel group from 20.9 +/- 6.1 to 13.8 +/- 2.1 mmHg (P = 0.000012) and in the T-flux group from 21.1 +/- 6.2 to 14.1 +/- 1.9 mmHg (P = 0.000006). There was no statistically significant difference between the number of antiglaucoma medications used in either group (P = 0.389). Complete success rates were 69.8% and 61.3%, respectively (P = 0.064) and qualified success rates were 93.2% and 84.1%, respectively (P = 0.034). There were no significant differences in complications between the two groups.
Despite the obtained statistical differences between the investigated groups in the scope of the qualified success rate, the result should not be treated as reliable from a clinical point of view. The influence of the kind of implant on the obtained result and the nature of the decompression space would require confirmation by ultrasound biomicroscopy (UBM), and by analysis of histological specimens but these were not performed. It should also be noted that the groups were not numerous.
In the case of SK-gel and T-flux application, PDS demonstrates similar efficacy and safety although the qualified success rate in the case of PDS with T-flux is significantly lower after a 24-month follow-up. The study does not indicate the cause of the observed changes but the nature of the intrascleral lake created by the implants used and its role in IOP regulation may be essential.
比较超声乳化 - 深层巩膜切除术（PDS）联合可吸收 SK-gel 或不可吸收 T-flux 植入的疗效和安全性。
本研究纳入了接受 PDS 联合 SK-gel（32 只眼）和 T-flux（20 只眼）治疗的患者。原发性开角型青光眼患者，尽管接受了最大耐受药物治疗，但仍无法控制眼内压（IOP）（>或=21mmHg），或视野和白内障进展，是手术的适应证。统计分析采用 Mann-Whitney U 检验、Student's t 检验、配对序列 Wilcoxon 检验和方差分析。采用 Kaplan-Meier 方法进行生存分析。
最佳矫正视力（BCVA）、IOP、眼前段和眼后段以及抗青光眼药物的使用数量。术后第 1、7 天以及 1、3、6、12、18 和 24 个月进行随访检查。完全成功率定义为 IOP<或=18mmHg 且无需药物治疗；部分成功率定义为 IOP<或=18mmHg 且需要药物治疗。
经过 24 个月的随访，SK-gel 组的平均 IOP 从 20.9+/-6.1mmHg 降至 13.8+/-2.1mmHg（P=0.000012），T-flux 组从 21.1+/-6.2mmHg 降至 14.1+/-1.9mmHg（P=0.000006）。两组抗青光眼药物的使用数量无统计学差异（P=0.389）。完全成功率分别为 69.8%和 61.3%（P=0.064），部分成功率分别为 93.2%和 84.1%（P=0.034）。两组并发症无统计学差异。
尽管在部分成功率方面，两组之间的统计学差异有统计学意义，但从临床角度来看，结果不应被视为可靠。植入物种类对结果的影响以及减压空间的性质需要通过超声生物显微镜（UBM）和组织学标本分析来证实，但这些都没有进行。还应注意到，两组的数量都不多。
在 SK-gel 和 T-flux 应用的情况下，PDS 具有相似的疗效和安全性，尽管在 24 个月的随访后，T-flux 组的部分成功率显著降低。本研究未指出观察到的变化的原因，但植入物所形成的巩膜下腔的性质及其在调节 IOP 中的作用可能至关重要。
