Bandello F, Polito A, Del Borrello M, Zemella N, Isola M
Department of Ophthalmology, University of Udine, P le S Maria della Misericordia, 33100 Udine, Italy.
Br J Ophthalmol. 2005 Jul;89(7):864-70. doi: 10.1136/bjo.2004.051060.
To compare the effectiveness of "light" versus "classic" laser photocoagulation in diabetic patients with clinically significant macular oedema (CSMO).
A prospective randomised pilot clinical trial in which 29 eyes of 24 diabetic patients with mild to moderate non-proliferative diabetic retinopathy (NPDR) and CSMO were randomised to either "classic" or "light" Nd:YAG 532 nm (frequency doubled) green laser. "Light" laser treatment differed from conventional ("classic") photocoagulation in that the energy employed was the lowest capable to produce barely visible burns at the level of the retinal pigment epithelium. Primary outcome measure was the change in foveal retinal thickness as measured by optical coherence tomography (OCT); secondary outcomes were the reduction/elimination of macular oedema on contact lens biomicroscopy and fluorescein angiography, change in visual acuity, contrast sensitivity, and mean deviation in the central 10 degrees visual field. Examiners were masked to patients' treatment.
14 eyes were assigned to "classic" and 15 were assigned to "light" laser treatment. At 12 months, seven (50%) of 14 eyes treated with "classic" and six (43%) of 14 eyes treated with "light" laser had a decrease of foveal retinal thickness on OCT (p = 0.79). A comparison of reduction/elimination of oedema, visual improvement, visual loss, change in contrast sensitivity, and mean deviation in the central 10 degrees showed no statistical difference between the groups at 12 months (p>0.05 for all groups).
This study suggests that "light" photocoagulation for CSMO may be as effective as "classic" laser treatment, thus supporting the rationale for a larger equivalence trial.
比较“轻度”与“传统”激光光凝术治疗糖尿病性黄斑水肿（CSMO）患者的疗效。
一项前瞻性随机试验性临床试验，将24例患有轻度至中度非增殖性糖尿病视网膜病变（NPDR）和CSMO的糖尿病患者的29只眼随机分为“传统”或“轻度”钕：钇铝石榴石532纳米（倍频）绿色激光治疗组。“轻度”激光治疗与传统（“经典”）光凝术的不同之处在于，所使用的能量是在视网膜色素上皮水平产生勉强可见烧伤的最低能量。主要观察指标是通过光学相干断层扫描（OCT）测量的黄斑视网膜厚度变化；次要观察指标是接触镜生物显微镜检查和荧光素血管造影检查中黄斑水肿的减轻/消除、视力变化、对比敏感度以及中心10度视野的平均偏差。检查人员对患者的治疗情况不知情。
14只眼被分配到“传统”激光治疗组，15只眼被分配到“轻度”激光治疗组。在12个月时，接受“传统”激光治疗的14只眼中有7只（50%），接受“轻度”激光治疗的14只眼中有6只（43%）在OCT上黄斑视网膜厚度降低（p = 0.79）。在12个月时，两组在水肿减轻/消除、视力改善、视力下降、对比敏感度变化以及中心10度平均偏差方面的比较无统计学差异（所有组p>0.05）。
本研究表明，CSMO的“轻度”光凝术可能与“传统”激光治疗同样有效，从而支持了进行更大规模等效性试验的理论依据。
