Cillino Salvatore, Di Pace Francesco, Casuccio Alessandra, Lodato Gaetano
Istituto di Clinica Oculistica, Università di Palermo, Palermo, Italy.
Ophthalmologica. 2005 Sep-Oct;219(5):281-6. doi: 10.1159/000086112.
To compare IOP behavior after deep sclerectomy (DS) and trabeculectomy with the Crozafon-De Laage Punch (TP), using low-dosage intraoperative mitomycin C (MMC) in both techniques.
The study was a prospective randomized clinical trial. All patients met inclusion and exclusion criteria, and were scheduled for glaucoma surgery. Forty patients were randomized to undergo either a nonpenetrating DS with MMC (DSMMC) (19 eyes) or a TP with MMC (TPMMC) (21 eyes). Postoperative examinations were performed at the 1st day, the 1st, 2nd and 3rd weeks and the 1st, 3rd, 6th, 9th and 12th months. Postoperative complications, number of antiglaucoma medications and the IOP level were checked at each control. Complete success (without antiglaucoma medications) and qualified success (with or without medications) were assessed at two target IOP levels, namely < or = 21 and < or = 17 mm Hg in both groups. Moreover, the success rates at < or = 21 mm Hg target IOP level were compared with those from previous series of patients who had undergone DS without MMC (historical control group).
Data from all eyes were available until the 12th month. The mean preoperative IOP +/- SD was 29.6 +/- 5.8 mm Hg in DSMMC eyes, 28.0 +/- 6.0 in TPMMC eyes; the mean IOP at the 1st postoperative day was 12.5 +/- 4.2 and 13.9 +/- 6.5 mm Hg, while at the endpoint the mean IOP was 14.5 +/- 4.0 and 16.1 +/- 3.8, respectively, with significant reduction (p < 0.0005) of the preoperative IOP in both groups. Complete success (< or = 21 mm Hg target IOP) in 15 eyes (78.9%) of the DSMMC group and in 15 eyes (71.4%) of the TPMMC group was respectively found, while qualified success was achieved in all the eyes. When a < or = 17 mm Hg target IOP was considered, complete success in 12 eyes (63.1%) and 13 eyes (61.9%), and qualified success in 13 eyes (68.4%) and 15 eyes (71.4%) were found in the DSMMC and TPMMC groups, respectively. No significant intergroup differences were found in terms of success rate. There is no statistical significance in the Kaplan-Meier cumulative survival curves as for complete and qualified success rate in both surgical groups for a < or = 17 mm Hg target IOP (log rank, p = 0.918 and p = 0.429, respectively). As for the frequency of postoperative complications, hypotony and shallow anterior chamber were significantly more frequent in TPMMC when compared with the DSMMC group. The historical comparison between the DSMMC group and simple DS cases shows no significant difference between the groups, with a mild positive trend in DSMMC when compared with DS eyes.
Both techniques, DSMMC and TPMMC, control IOP efficaciously at our endpoint. Our results indicate that low-dosage MMC can be considered a mild enhancement of DS IOP lowering effect without any negative effect on the well-known intra- and postoperative safety of the technique.
比较深层巩膜切除术（DS）和使用Crozafon - De Laage冲孔术的小梁切除术（TP）术后眼压变化情况，两种手术均术中使用低剂量丝裂霉素C（MMC）。
本研究为前瞻性随机临床试验。所有患者均符合纳入和排除标准，并计划接受青光眼手术。40例患者被随机分为两组，一组接受含MMC的非穿透性DS（DSMMC）（19只眼），另一组接受含MMC的TP（TPMMC）（21只眼）。术后第1天、第1、2、3周以及第1、3、6、9、12个月进行检查。每次检查时记录术后并发症、抗青光眼药物使用数量及眼压水平。在两组的两个目标眼压水平，即≤21和≤17 mmHg时，评估完全成功（无需使用抗青光眼药物）和合格成功（使用或未使用药物）情况。此外，将DSMMC组在≤21 mmHg目标眼压水平的成功率与之前未使用MMC进行DS手术的患者系列（历史对照组）进行比较。
所有眼的数据均记录至第12个月。DSMMC组术前平均眼压±标准差为29.6±5.8 mmHg，TPMMC组为28.0±6.0 mmHg；术后第1天平均眼压分别为12.5±4.2和13.9±6.5 mmHg，而在终点时平均眼压分别为14.5±4.0和16.1±3.8 mmHg，两组术前眼压均显著降低（p<0.0005）。DSMMC组15只眼（78.9%）和TPMMC组15只眼（71.4%）达到完全成功（目标眼压≤21 mmHg），所有眼均达到合格成功。当目标眼压≤17 mmHg时，DSMMC组12只眼（63.1%）和TPMMC组13只眼（61.9%）达到完全成功，DSMMC组13只眼（68.4%）和TPMMC组15只眼（71.4%）达到合格成功。两组成功率方面未发现显著组间差异。对于目标眼压≤17 mmHg，两个手术组在完全成功和合格成功率的Kaplan - Meier累积生存曲线方面无统计学意义（对数秩检验，p分别为0.918和0.429）。术后并发症方面，与DSMMC组相比，TPMMC组低眼压和前房变浅更为常见。DSMMC组与单纯DS病例的历史对照比较显示两组无显著差异，与DS手术眼相比，DSMMC组有轻微的正向趋势。
DSMMC和TPMMC两种技术在我们的研究终点均能有效控制眼压。我们的结果表明，低剂量MMC可被视为对DS降低眼压效果的轻度增强，且对该技术众所周知的术中及术后安全性无任何负面影响。
