Raizada Seemant, Al Kandari Jamal, Al Diab Fahad, Al Sabah Khalid, Kumar Niranjan, Mathew Sebastian
Vitreo-Retinal Unit, Al Bahar Eye Center, IBN Sina Hospital, Safat; Department of Ophthalmology, Dasman Diabetes Institute, Safat, Kuwait.
Indian J Ophthalmol. 2015 Jun;63(6):504-10. doi: 10.4103/0301-4738.162602.
The aim of this study was to compare the effectiveness of pars plana vitrectomy (PPV) and removal of the internal limiting membrane (ILM) with three, monthly, intravitreal bevacizumab (IVB) injections for refractory diabetic macular edema.
This was a prospective, randomized, comparative, interventional study. Forty-four patients were enrolled and randomized in two groups. Twenty-two eyes enrolled in Group I received three IVB injections at monthly interval. Twenty-two eyes were enrolled in Group II which underwent PPV with ILM removal. The primary outcomes measured were: (1) Best corrected logMAR visual acuity (BCVA) using Snellen's visual acuity chart. (2) Central macular thickness (CMT) on optical coherence tomography. The secondary outcome measures were: Complication rates like (1) progression of lens opacities, (2) high intraocular pressure needing further treatment/procedure, (3) development of vitreous hemorrhage related to the procedure employed, (4) retinal detachment and (5) severe inflammation/endophthalmitis.
In Group I (IVB): 3 (13.6%) eyes showed no change in BCVA; 3 (13.6%) eyes reported decrease in BCVA and 16 (72.8%) eyes showed improvement in BCVA; (P = 0.0181). In Group II (PPV): 4 (18.2%) eyes showed no change in BCVA; 5 (22.7%) eyes showed decrease and 13 (59.1%) eyes showed improvement in BCVA (P = 0.0281). Mean decrease in CMT in IVB group was 108.45 μ, whereas mean decrease in CMT in PPV group was 161.36 μ. No major complications were seen in either group.
Posttreatment decrease in CMT was more in PPV group and vision improvement more in IVB group. However, no statistically significant difference between the two methods was found.
本研究的目的是比较玻璃体切除术(PPV)联合去除内界膜(ILM)与每月三次玻璃体内注射贝伐单抗(IVB)治疗难治性糖尿病性黄斑水肿的效果。
这是一项前瞻性、随机、对比、干预性研究。44例患者入组并随机分为两组。第一组的22只眼每隔一个月接受三次IVB注射。第二组的22只眼接受PPV联合ILM去除术。测量的主要指标为:(1)使用斯内伦视力表测量的最佳矫正对数最小分辨角视力(BCVA)。(2)光学相干断层扫描测量的中心黄斑厚度(CMT)。次要指标包括:并发症发生率,如(1)晶状体混浊进展,(2)需要进一步治疗/手术的高眼压,(3)与所采用手术相关的玻璃体积血的发生,(4)视网膜脱离,以及(5)严重炎症/眼内炎。
在第一组(IVB组)中:3只眼(13.6%)的BCVA无变化;3只眼(13.6%)的BCVA下降,16只眼(72.8%)的BCVA改善(P = 0.0181)。在第二组(PPV组)中:4只眼(18.2%)的BCVA无变化;5只眼(22.7%)下降,13只眼(59.1%)改善(P = 0.0281)。IVB组CMT的平均下降值为108.45μm,而PPV组CMT的平均下降值为161.36μm。两组均未观察到重大并发症。
PPV组治疗后CMT下降更多,IVB组视力改善更明显。然而,两种方法之间未发现统计学上的显著差异