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

Hernández‐Da Mota 2010.

Methods Prospective, randomised, open‐label study
Country: Mexico
Participants Number: 40
Age: Mean 55.7 (both groups)
Sex: Not given
Inclusion criteria:
  • Presence of advanced PDR

  • Presence of TRD threatening the macula

  • HbA1c < 7


Exclusion criteria:
  • Macular involvement of retinal detachment

  • Iris rubeosis

  • Cataract ‐ when precluding proper evaluation of the fundus

  • No perception of light vision

  • Macular ischaemia

Interventions Intervention:
  • IVB (1.25 mg/0.05 ml), 48 hours before vitrectomy (n = 20)


Comparator:
  • No IVB (n = 20)

Outcomes Primary outcomes:
  • BCVA

  • Feasibility of surgery (intraoperative bleeding, break formation)

  • Postoperative complications (POVCH, iris rubeosis, and retinal detachment)


Follow‐up: 1 week, 3 and 6 months
Notes No response from authors to correspondence asking for clarification of POVCH definitions.
Trial registration number: not reported
Date study conducted: not reported
Funding: reported none
Conflict of interest: reported that there were none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomly assigned into two groups"
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants were not masked to treatment group
Blinding of outcome assessment (detection bias) 
 All outcomes High risk "For all patients, visual acuity and intraocular pressure were measured and recorded before PPV in a standardized, masked manner"
However, not clearly stated whether outcome assessment was always masked and whether other outcomes, such as intraocular bleeding, were masked
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Although not directly stated, it is clear from the results that all participants completed the stated follow‐up
Selective reporting (reporting bias) Low risk All outcomes were reported