State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, 54 South Xianlie Road, Guangzhou, Guangdong, China.
Electrophysiology Laboratory, Department of Ophthalmology, University Hospitals, Case Western Reserve University, Cleveland, OH, USA.
Lasers Med Sci. 2022 Dec;37(9):3561-3569. doi: 10.1007/s10103-022-03635-8. Epub 2022 Sep 7.
To find a new approach of pan-retinal photocoagulation (PRP) with less damage to the retina in the treatment of severe non-proliferative diabetic retinopathy (NPDR), this study compared functional changes in the retina after subthreshold and threshold PRP treatment in severe NPDR eyes.
Post hoc analysis of a randomized clinical trial was conducted in this study. Seventy eyes of 35 patients with bilateral, symmetric, severe NPDR were enrolled. Two eyes from the same patient were randomized into two groups, one eye received subthreshold PRP (S-PRP) and the other eye received threshold PRP (T-PRP). Comprehensive ophthalmological evaluations were performed on the baseline and every 3 months for 1 year. Visual field (VF) and full-field electroretinography (ERG) were performed on the baseline and repeated at month 12.
During the 12-month follow-up, 4 eyes (11.4%) in the S-PRP group and 3 eyes (8.6%) in the T-PRP group progressed to proliferative diabetic retinopathy (PDR) stage, and there was no statistical difference in PDR progression rate between the two groups (P = 0.69). In addition, the changes in best-corrected visual acuity (BCVA) from baseline to month 12 between the two groups had no statistical difference (P = 0.30). From baseline to month 12, changes in central VF between the two groups had no statistical difference (P = 0.25), but changes in total score points of peripheral VF in the S-PRP group (- 242.1 ± 210.8 dB) and the T-PRP group (- 308.9 ± 209.7 dB) were statistically significant (P = 0.03). At month 12, ERG records showed that the amplitude of dark-adapted 0.01 ERG, dark-adapted 3.0 ERG, oscillatory potentials, light-adapted 3.0 ERG, and 30 Hz flicker ERG of both groups were significantly decreased from the baseline (P < 0.05). In addition, the amplitude of each ERG record in the S-PRP group decreased significantly less than those in the T-PRP group (P < 0.05).
Subthreshold PRP is as effective as threshold PRP for preventing severe NPDR progress to PDR within 1 year with less damage to periphery VF and retinal function.
gov Identifier: NCT01759121.
为了寻找一种新的视网膜全光凝术(PRP)方法,以减少对严重非增生性糖尿病视网膜病变(NPDR)患者视网膜的损伤,本研究比较了亚阈值和阈值 PRP 治疗严重 NPDR 眼后视网膜功能的变化。
本研究为一项随机临床试验的事后分析。纳入了 35 名双侧、对称、严重 NPDR 患者的 70 只眼。同一名患者的两只眼随机分为两组,一组接受亚阈值 PRP(S-PRP),另一组接受阈值 PRP(T-PRP)。在基线和 1 年内每 3 个月进行全面眼科评估。在基线和第 12 个月重复进行视野(VF)和全视野视网膜电图(ERG)检查。
在 12 个月的随访中,S-PRP 组有 4 只眼(11.4%)和 T-PRP 组有 3 只眼(8.6%)进展为增生性糖尿病视网膜病变(PDR)期,两组 PDR 进展率无统计学差异(P=0.69)。此外,两组从基线到第 12 个月的最佳矫正视力(BCVA)变化无统计学差异(P=0.30)。从基线到第 12 个月,两组中央 VF 的变化无统计学差异(P=0.25),但 S-PRP 组(-242.1±210.8 dB)和 T-PRP 组(-308.9±209.7 dB)的外周 VF 总分变化有统计学意义(P=0.03)。在第 12 个月,ERG 记录显示两组暗适应 0.01 ERG、暗适应 3.0 ERG、振荡电位、明适应 3.0 ERG 和 30 Hz 闪烁 ERG 的振幅均较基线显著降低(P<0.05)。此外,S-PRP 组各 ERG 记录的振幅降低幅度明显小于 T-PRP 组(P<0.05)。
在 1 年内,亚阈值 PRP 预防严重 NPDR 进展为 PDR 的效果与阈值 PRP 相同,对周边 VF 和视网膜功能的损伤较小。
gov 标识符:NCT01759121。