Lopes João F, Moster Marlene R, Wilson Richard P, Altangerel Undraa, Alvim Heryberto S, Tong Melissa G, Fontanarosa Joann, Steinmann William C
Glaucoma Service, Wills Eye Hospital, Philadelphia, Pennsylvania 19107, USA.
Ophthalmology. 2006 May;113(5):756-60. doi: 10.1016/j.ophtha.2006.01.040.
To investigate the efficacy of subconjunctival sodium hyaluronate 2.3% in increasing the success rate of glaucoma filtering surgery and promoting filtering blebs with characteristics presumed to predict better success.
Randomized controlled clinical trial.
Fifty-five patients scheduled for glaucoma surgery.
Patients underwent routine trabeculectomy, with or without phacoemulsification and intraocular lens implantation. In the study group (n = 28), sodium hyaluronate 2.3% was injected between the scleral and conjunctival flaps at the conclusion of the surgery. In the control group (n = 27), balanced salt solution (BSS) was injected in the same fashion, in an unmasked design.
Surgical success was defined as (1) a complete success if the intraocular pressure (IOP) was 21 mmHg or less without any antiglaucoma medication, and (2) a qualified success if the IOP was 21 mmHg or less, with or without antiglaucoma medication. Patients requiring additional surgery, including needling, or with IOP more than 21 mmHg, even when receiving antiglaucoma medications, were considered to have failed treatment. Success rates in both groups were compared using Kaplan-Meier survival curves and the log-rank test. The morphologic characteristics of the filtering blebs were evaluated using the Indiana Bleb Appearance Grading Scale. Other outcome measures were IOP, visual acuity, need for antiglaucoma medication, and any complications.
Fifty-two patients completed the study (27 in the study group and 25 in the control group), with a mean follow-up of 12.3 months. Complete success rates were 77.8% for the study group and 84.0% for the control group 12 months after surgery (P>0.5); qualified success rates were 88.9% for the study group and 92.0% for the control group (P>0.6). Mean IOP decreased from 26.0+/-10.0 mmHg to 11.6+/-4.1 mmHg in the study eyes (P<0.001) and from 24.9+/-9.7 mmHg to 13.0+/-4.1 mmHg in the control eyes (P<0.001). Intraocular pressure measurements in both groups were similar at all visits (P>0.05). The study eyes had more diffuse blebs than the control eyes (62.5% > or =4 clock-hours vs. 22.7%; P = 0.012). Postoperative complications were similar in the study eyes (14.8%) and the control eyes (20.0%; P>0.6).
There was no difference in success rates in patients who received subconjunctival sodium hyaluronate 2.3% compared to BSS injections. Subconjunctival sodium hyaluronate 2.3% was associated with more diffuse blebs after filtering surgery.
探讨结膜下注射2.3%透明质酸钠对提高青光眼滤过手术成功率及促进具有预测更好手术效果特征的滤过泡形成的疗效。
随机对照临床试验。
55例计划行青光眼手术的患者。
患者接受常规小梁切除术，可联合或不联合超声乳化白内障吸除术及人工晶状体植入术。研究组（n = 28）在手术结束时于巩膜瓣和结膜瓣之间注射2.3%透明质酸钠。对照组（n = 27）以同样方式注射平衡盐溶液（BSS），采用非盲法设计。
手术成功定义为：（1）若眼压（IOP）在未使用任何抗青光眼药物的情况下≤21 mmHg，则为完全成功；（2）若眼压≤21 mmHg，无论是否使用抗青光眼药物，则为合格成功。需要额外手术（包括针刺）或眼压＞21 mmHg（即使使用抗青光眼药物）的患者被视为治疗失败。使用Kaplan-Meier生存曲线和对数秩检验比较两组的成功率。使用印第安纳滤过泡外观分级量表评估滤过泡的形态特征。其他观察指标包括眼压、视力、抗青光眼药物需求及任何并发症。
52例患者完成研究（研究组27例，对照组25例），平均随访12.3个月。术后12个月，研究组完全成功率为77.8%，对照组为84.0%（P＞0.5）；研究组合格成功率为88.9%，对照组为92.0%（P＞0.6）。研究组患眼眼压从26.0±10.0 mmHg降至11.6±4.1 mmHg（P＜(0.001)），对照组患眼眼压从24.9±9.7 mmHg降至13.0±4.1 mmHg（P＜(0.001)）。两组在所有随访时的眼压测量值相似（P＞0.05）。研究组患眼的滤过泡比对照组更弥散（62.5%≥4个钟点范围 vs. 22.7%；P = 0.012）。研究组患眼（14.8%）和对照组患眼（20.0%）的术后并发症相似（P＞0.6）。
与注射BSS相比，结膜下注射2.3%透明质酸钠的患者成功率无差异。结膜下注射2.3%透明质酸钠与滤过手术后更弥散的滤过泡相关。
