Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Ophthalmology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Ophthalmol Glaucoma. 2018 Jul-Aug;1(1):66-74. doi: 10.1016/j.ogla.2018.06.003. Epub 2018 Jul 6.
To report the 3-year outcome of trabeculectomy with mitomycin C (MMC)-soaked sponges versus intra-Tenon injection of MMC in eyes with uncontrolled primary open-angle glaucoma.
Randomized clinical trial.
Eighty-two consecutive patients with uncontrolled primary open-angle glaucoma.
Participants were randomized either to intra-Tenon injection of 0.1 ml of 0.01% MMC (TI group) or 0.02% subconjunctival application of MMC-soaked sponges (TS group). Patients were followed up for 3 years after surgery. The data for 73 eyes were included in the final analysis.
The primary outcome measure was the surgical success, defined as intraocular pressure (IOP) more than 5 mmHg and <21 mmHg, and IOP reduction of 20% or more from baseline, no reoperation for glaucoma, and no loss of light perception vision. Secondary outcome measures were IOP, glaucoma medications, best-corrected visual acuity (VA), bleb morphologic features according to the Indiana Bleb Appearance Grading Scale, complications, and endothelial cell count changes.
The cumulative probability of success at 3-year follow-up was 72.2% in the TI group and 65.1% in the TS group (P = 0.30). Uncontrolled IOP was the most common reason for failure. The mean preoperative IOP was 22.4±4.6 mmHg with an average of 3.1±1.0 medications. At 3 years, final IOP was 15.3±3.7 mmHg in the TI group and 16.4±3.5 mmHg in the TS group (P = 0.55). Mean glaucoma number of medications was 0.9±1.1 and 1.1±1.1 in the TI and TS groups, respectively (P = 0.54). Blebs tended to be more diffuse (P = 0.032), less vascularized (P = 0.013), and more shallow (P = 0.012) after intra-Tenon injection. Visual outcomes and endothelial cell changes were similar in both groups (P = 0.47 and P = 0.94, respectively).
Although the success rate and IOP reduction were comparable with both techniques, bleb morphologic parameters were more favorable after intra-Tenon injection of 0.1 ml of 0.01% MMC.
报告在伴有未控制的原发性开角型青光眼的眼中，与经 Tenon 囊下注射丝裂霉素 C（MMC）相比，小梁切除术联合应用 MMC 浸泡海绵的 3 年结果。
随机临床试验。
82 例连续的患有未控制的原发性开角型青光眼的患者。
参与者随机分为两组，一组接受经 Tenon 囊下注射 0.1ml0.01%MMC（TI 组），另一组接受 0.02%MMC 浸泡海绵的结膜下应用（TS 组）。术后随访 3 年。最终分析纳入了 73 只眼的数据。
主要观察指标为手术成功率，定义为眼压（IOP）大于 5mmHg 且小于 21mmHg，IOP 较基线降低 20%或更多，无需再次行青光眼手术，并且不丧失光感视力。次要观察指标为 IOP、青光眼药物、最佳矫正视力（VA）、根据印第安纳氏滤过泡外观分级量表评估的滤过泡形态特征、并发症和内皮细胞计数变化。
TI 组和 TS 组在 3 年随访时的累积成功率分别为 72.2%和 65.1%（P=0.30）。未控制的IOP 是最常见的失败原因。术前平均 IOP 为 22.4±4.6mmHg，平均使用 3.1±1.0 种药物。3 年后，TI 组的最终 IOP 为 15.3±3.7mmHg，TS 组为 16.4±3.5mmHg（P=0.55）。TI 组和 TS 组的平均青光眼药物数量分别为 0.9±1.1 和 1.1±1.1（P=0.54）。经 Tenon 囊下注射后，滤过泡往往更弥散（P=0.032）、血管化程度更低（P=0.013）、更浅（P=0.012）。两组的视力结果和内皮细胞变化相似（P=0.47 和 P=0.94）。
尽管两种技术的成功率和 IOP 降低相似，但经 Tenon 囊下注射 0.1ml0.01%MMC 后，滤过泡形态参数更有利。
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