Russo V, Scott I U, Stella A, Balducci F, Cosma A, Barone A, Delle Noci N
Institute of Ophthalmology, University of Foggia, Foggia - Italy.
Eur J Ophthalmol. 2008 Sep-Oct;18(5):751-7. doi: 10.1177/112067210801800515.
To compare the intraocular pressure (IOP)-lowering effect and complication rate of nonpenetrating deep sclerectomy (NPDS) with reticulated hyaluronic acid (SK-GEL) scleral implant versus traditional punch trabeculectomy (PT) in the management of primary open angle glaucoma (POAG).
Prospective, randomized comparative study including 93 patients with uncontrolled POAG. Group 1 (43 eyes) underwent NPDS with SK-GEL scleral implant; Group 2 (50 eyes) underwent PT. Mitomycin C (0.2 mg/mL) was applied intraoperatively in both techniques. Study follow-up evaluations were conducted at 36 and 48 months. Complete success indicated the achievement of the target IOP without antiglaucoma medications, while qualified success indicated the same goal with medications. These categories were assessed at two target IOP levels, <21 mmHg and <18 mmHg.
At 36 months for complete and qualified success with a <21 and <18 mmHg target IOP, no significant differences were noted between the two groups. At 48 months postprocedure when a <21 mmHg IOP target was considered, the rate of eyes that achieved complete success was 51.1% in the NPDS group versus 72% in the PT group (p<0.05). As for the <18 mmHg IOP target, the rate of eyes that achieved complete success was 32.5% in the NPDS group versus 44% in the PT group (p<0.05). Complications occurred significantly more frequently after PT than after NPDS.
The IOP-lowering effects of the two procedures were comparable at 36 months. At 48 months PT showed a significantly higher rate of complete success compared with NPDS. Complications were more frequent after PT than after NPDS.
比较在原发性开角型青光眼（POAG）治疗中，采用网状透明质酸（SK - GEL）巩膜植入物的非穿透性深层巩膜切除术（NPDS）与传统的小梁切除术（PT）降低眼压（IOP）的效果及并发症发生率。
前瞻性、随机对照研究，纳入93例眼压控制不佳的POAG患者。第1组（43只眼）接受采用SK - GEL巩膜植入物的NPDS；第2组（50只眼）接受PT。两种手术术中均应用丝裂霉素C（0.2 mg/mL）。研究随访评估在36个月和48个月时进行。完全成功定义为在未使用抗青光眼药物的情况下达到目标眼压，而合格成功定义为使用药物达到相同目标。在两个目标眼压水平，即<21 mmHg和<18 mmHg下评估这些类别。
在36个月时，对于目标眼压<21 mmHg和<18 mmHg的完全成功和合格成功情况，两组之间未发现显著差异。在术后48个月，当考虑目标眼压<21 mmHg时，NPDS组完全成功的眼数比例为51.1%，而PT组为72%（p<0.05）。至于目标眼压<18 mmHg，NPDS组完全成功的眼数比例为32.5%，而PT组为44%（p<0.05）。PT术后并发症的发生频率显著高于NPDS术后。
两种手术在36个月时降低眼压的效果相当。在48个月时，与NPDS相比，PT的完全成功率显著更高。PT术后并发症比NPDS术后更频繁。
