Ophthalmology Department, Ain Shams University, Cairo, Egypt.
Affiliated as vitreoretinal consultant, Hadi hospital, Jabriya, Kuwait.
BMC Ophthalmol. 2020 Apr 6;20(1):130. doi: 10.1186/s12886-020-01401-4.
To compare efficacy and safety of intravitreal aflibercept (IVA) injection with panretinal photocoagulation (PRP) versus early vitrectomy for diabetic vitreous hemorrhage (VH).
Prospective, randomized study that included 34 eyes with diabetic VH. They were divided into two groups, Group Ι (17 eyes) received three successive IVA injections followed by PRP and group ΙΙ (17 eyes) for whom early vitrectomy was done. Follow up was carried out after one, two, three, six and nine months. The primary outcome measure was change in the mean best corrected visual acuity (BCVA) after nine months, secondary outcome measures were mean duration of clearance of VH and rate of recurrent hemorrhage with any additional treatment in both groups. Complications were reported.
There was no statistically significant difference regarding initial demographic criteria between both groups. The mean final log MAR BCVA was statistically better than the initial BCVA in both groups (0.51 ± 0.20, 1.17 ± 0.48 for group I and 0.48 ± 0.18, 1.44 ± 0.44 for group II, P < 0.001). There was no statistically significant difference between both groups regarding the mean final Log Mar BCVA (0.51 ± 0.20 for group I, 0.48 ± 0.18 for group II, p ≥ 0.05), the mean duration of clearance of VH was 7.8 ± 1.8 weeks, 5 days for group I and II respectively. PRP was completely done for all eyes in group I after three months. The difference in the recurrence rate between group I (29.4%) and group II (11.8%) was statistically significant (p < 0.05). Vitrectomy was done for three eyes (17.6%) due to recurrent non-resolving VH in group I. late recurrent VH occurred in two eyes (11.8%) in group II, IVA was given with complete clearance of the hemorrhage. No vision threatening complications were reported in both groups.
Both intravitreal injection of aflibercept followed by PRP and early vitrectomy are effective and safe modalities for treatment of diabetic vitreous hemorrhage. Early vitrectomy leads to faster vision gain with less incidence of recurrence than intravitreal injection.
Randomized clinical trial under the number of NCT04153253 on November 6, 2019 "Retrospectively registered".
比较玻璃体内注射阿柏西普（IVA）联合全视网膜光凝（PRP）与早期玻璃体切除术治疗糖尿病玻璃体积血（VH）的疗效和安全性。
前瞻性随机研究纳入 34 只患有糖尿病 VH 的眼。将其分为两组，组 Ι（17 只眼）接受三次连续 IVA 注射，随后行 PRP，组 ΙΙ（17 只眼）行早期玻璃体切除术。在 1、2、3、6 和 9 个月进行随访。主要观察指标为 9 个月后平均最佳矫正视力（BCVA）的变化，次要观察指标为两组 VH 清除的平均持续时间和任何额外治疗后再出血的发生率。报告并发症。
两组间初始人口统计学标准无统计学差异。两组的最终平均对数最小分辨角视力（LogMAR BCVA）均显著优于初始 BCVA（组 I 为 0.51±0.20，1.17±0.48，组 II 为 0.48±0.18，1.44±0.44，P<0.001）。两组的最终平均 Log Mar BCVA 无统计学差异（组 I 为 0.51±0.20，组 II 为 0.48±0.18，P≥0.05），VH 清除的平均持续时间分别为 7.8±1.8 周和 5 天。组 I 所有眼均在 3 个月后行完全 PRP。组 I（29.4%）和组 II（11.8%）的复发率差异有统计学意义（P<0.05）。组 I 因 VH 持续不吸收行玻璃体切除术 3 眼（17.6%）。组 II 有 2 眼（11.8%）发生迟发性 VH 复发，给予 IVA 治疗后出血完全吸收。两组均无威胁视力的并发症。
玻璃体内注射阿柏西普联合 PRP 和早期玻璃体切除术都是治疗糖尿病玻璃体积血的有效且安全的方法。与玻璃体注射相比，早期玻璃体切除术视力恢复更快，复发率更低。
2019 年 11 月 6 日在 NCT04153253 号进行的随机临床试验“回顾性注册”。
