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

Uva 1996.

Methods Parallel‐group randomised controlled trial, 1 eye per person
Participants Country: Italy
Number of participants (eyes): 30 (30)
% women: 47%
Average age: 54.1 years (range 45 to 60)
Risk of trabeculectomy failure: low
Inclusion criteria:

  • primary open‐angle glaucoma uncontrolled with medication or laser therapy


Exclusion criteria:

  • previous ocular surgery

  • aged 60 years or more

  • had been on antiglaucoma medication for less than 3 years
Interventions

  • MMC (15 eyes)

    • Application: intraoperative sponge application

    • Dose: 0.2 mg/ml for 2 minutes

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

  • 5‐FU (15 eyes)

    • Application: intraoperative sponge application

    • Dose: 50 mg/ml was applied for 5 minutes

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


Limbal flap was used that was closed with 10‐0 nylon suture. 1% atropine, antibiotic and steroid was applied at the time of surgery. Conjunctiva was closed with 8‐0 polyglactin synthetic suture
Outcomes Postoperative IOP
Visual acuity
Postoperative complications
Follow‐up: Mean follow‐up 292 days +/‐ 46.1 days
Notes Date study conducted: Not reported
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 Randomised with a "table of numbers" technique
Allocation concealment (selection bias) Unclear risk No statement made
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Participant masking carried out given same surgical procedure for both antimetabolite interventions. Surgeons are presumed to not be masked given different duration of antimetabolite application. No mention of follow‐up masking
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Commented on all intended outcomes. Short period of follow‐up with all participants recorded within similar follow‐up period
Selective reporting (reporting bias) Low risk Stated outcome measures in the methods were reported in the results
Other bias Unclear risk No obvious further bias