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. 2015 Aug 7;2015(8):CD008214. doi: 10.1002/14651858.CD008214.pub3

Manabe 2015.

Methods Prospective, double‐masked randomised controlled trial
Country: Japan
Participants Number: 62 people (66 eyes)
Age: average 60 years (range 20 to 82)
Sex: 82% male
Inclusion criteria:
  • Diagnosed as having an indication for primary vitrectomy because of persistent vitreous haemorrhage for over 3 months and TRD caused by PDR; or fundus findings of proliferative changes or vitreous haemorrhage in people with iris neovascularisation or neovascular glaucoma


Exclusion criteria:
  • Intraocular surgery or retinal photocoagulation within 3 months before the study

  • Intravitreal injection of drugs or sub‐Tenon injection of steroids within 3 months before the study

  • Cerebrovascular infarction or myocardial infarction within 3 months before the study

Interventions Intervention:
  • IVB 0.16 mg/0.05 ml) 1 day before vitrectomy (n= 32)


Comparator:
  • Sham injection 1 day before vitrectomy (n=34)

Outcomes Primary outcome:
  • Frequency of reoperation due to postoperative recurrent vitreous haemorrhage within 4 weeks after vitrectomy


Secondary outcome measures:
  • Numbers of intraoperative laser and endodiathermy spots

  • Frequency of postoperative recurrent vitreous haemorrhage within 4 weeks after vitrectomy

  • Concentration of VEGF in vitreous at the beginning of surgery

Notes Trial registration number: NCT01854593
Date study conducted: June 2012 to August 2013
Funding: not reported
Conflict of interest: reported "none"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Low risk "...were randomised using the envelop method"
"Both the investigators and patients were masked to the treatment assignment".
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "Both the investigators and patients were masked to the treatment assignment".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "All postoperative examinations were performed by three vitreoretinal surgeons (H.S., T.H., H.N.) who also were masked to the study group allocation".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised participants were followed up for 1 month
Selective reporting (reporting bias) Low risk All outcomes on trial registry entry reported