Nikkhah Homayoun, Ghazi Hossein, Razzaghi Mohammad Reza, Karimi Saeed, Ramezani Alireza, Soheilian Masoud
Torfe and Imam Hossein medical centers, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Ophthalmology Department and Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Int Ophthalmol. 2018 Feb;38(1):313-321. doi: 10.1007/s10792-017-0469-7. Epub 2017 Feb 6.
To determine the clinical efficacy of extended targeted retinal photocoagulation (ETRP) compared to conventional panretinal photocoagulation (CPRP) in proliferative diabetic retinopathy (PDR).
In a single-masked randomized clinical trial, 270 eyes of 234 patients with naïve early or high-risk PDR were randomly assigned to receive either CPRP or ETRP (135 eyes, each treatment arm). Best-corrected visual acuity (BCVA) measurement, fundus examination, wide-field fluorescein angiography (WFFA) and optical coherence tomography were carried out before and 3 months after retinal photocoagulation. Primary outcome was early PDR regression, specified as reduction in retinal neovascularization based on WFFA at 3 months. Secondary outcomes were BCVA and central macular thickness (CMT) changes.
There were significantly more high-risk PDR eyes in ETRP group compared to CPRP (109 and 94 eyes, respectively, P = 0.04). Early PDR regression occurred in 71.9 and 64.4% of eyes in the ETRP and CPRP groups, respectively (P = 0.19). The mean number of applied laser spots in the ETRP was significantly fewer than CPRP (1202 vs. 1360, respectively, P < 0.001). Mean BCVA at baseline and 3 months post-laser were 0.37 ± 0.26 and 0.47 ± 0.19 logMAR in the ETRP arm, respectively. In the CPRP arm these values were 0.40 ± 0.27 and 0.47 ± 0.24 logMAR, respectively. Although mean BCVA decreased significantly in both treatment arms (ETRP P < 0.001, CPRP P = 0.009), the difference was not significant between arms (P = 0.68). CMT increased significantly in both groups (ETRP 41.08 μm, P < 0.001, CPRP 33.31 μm, P < 0.001). Nevertheless, the difference between the groups was not significant (P = 0.26).
ETRP with fewer number of laser spots may be an appropriate alternative to CPRP in PDR regression at least through 3 months.
NCT01232179.
比较延长靶向视网膜光凝术（ETRP）与传统全视网膜光凝术（CPRP）治疗增殖性糖尿病视网膜病变（PDR）的临床疗效。
在一项单盲随机临床试验中，将234例初诊为早期或高危PDR患者的270只眼随机分为两组，分别接受CPRP或ETRP治疗（每组135只眼）。在视网膜光凝术前及术后3个月进行最佳矫正视力（BCVA）测量、眼底检查、广角荧光素血管造影（WFFA）及光学相干断层扫描。主要结局指标为早期PDR消退，定义为3个月时基于WFFA的视网膜新生血管减少。次要结局指标为BCVA及中心黄斑厚度（CMT）变化。
与CPRP组相比，ETRP组高危PDR眼更多（分别为109只眼和94只眼，P = 0.04）。ETRP组和CPRP组分别有71.9%和64.4%的眼出现早期PDR消退（P = 0.19）。ETRP组应用的激光光斑平均数量显著少于CPRP组（分别为1202个和1360个，P < 0.001）。ETRP组激光治疗前及治疗后3个月的平均BCVA分别为0.37±0.26和0.47±0.19 logMAR。CPRP组的这些值分别为0.40±0.27和0.47±0.24 logMAR。虽然两个治疗组的平均BCVA均显著下降（ETRP组P < 0.001，CPRP组P = 0.009），但两组间差异无统计学意义（P = 0.68）。两组CMT均显著增加（ETRP组增加41.08μm，P < 0.001，CPRP组增加33.31μm，P < 0.001）。然而，两组间差异无统计学意义（P = 0.26）。
至少在3个月内，激光光斑数量较少的ETRP可能是PDR消退治疗中CPRP的合适替代方法。
NCT01232179
