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. 2015 Nov 6;2015(11):CD006259. doi: 10.1002/14651858.CD006259.pub2

Sisto 2007.

Methods Parallel‐group randomised controlled trial, 1 eye per person
Participants Country: Italy
Number of participants (eyes): 40 (40)
% women: 35%
Average age: 61 years (range 36 to 75)
Risk of trabeculectomy failure: high
Inclusion criteria:
  • neovascular glaucoma

  • IOP < 21 mmHg and resistant to medical therapy

  • no previous ocular surgery

  • best corrected visual acuity > ‐1.5 logMAR units


Exclusion criteria: not reported
Interventions
  • MMC (22 eyes)

    • Application: intraoperative sponge application

    • Dose: 0.2 mg/ml for 2 minutes

    • Location: between the sclera and the Tenon's capsule

  • 5‐FU (18 eyes)

    • Application: postoperative injections, commencing on day 7, 2 injections per week for 2 weeks and then 1 injection per week for 6 weeks

    • Dose: 0.1 ml of 50 mg/ml

    • Location: subconjunctival injections near the bleb


Fornix‐based conjunctival flaps with single surgeon. No releasable sutures or suture lysis employed
Outcomes Success defined as IOP < 21 mmHg at final postoperative visit.
Qualified success defined if IOP < 21 mmHg with addition of topical treatment. Failure is uncontrolled IOP equal or above 21 mmHg or vision dropped to no perception of light.
Follow‐up: every 3 months in the first year, every 6 months thereafter to maximum 60 months (5 years)
Notes Date study conducted: January 1993 to November 2000
Conflict of interest: Not reported
Funding source: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 40 consecutive people with neovascular glaucoma selected.
"All eyes had been assigned with a computer generated randomization code."
Allocation concealment (selection bias) Unclear risk No statement made
Blinding (performance bias and detection bias) 
 All outcomes Low risk Surgeon not masked due to technique, but the follow‐up staff were masked on collecting postoperative data
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participant data included in analysis. However, length of follow‐up was variable and no statement was made regarding the participants lost to follow‐up.
Selective reporting (reporting bias) Low risk Success criteria defined in the methods
Other bias Unclear risk No attempted power calculations