| Methods |
Single‐centre double‐masked RCT. Study dates not reported. |
| Participants |
368 patients undergoing primary trabeculectomy in one eye with no previous surgical exposure. The trial was funded by the Medical Research Council and included patients from various ethnic groups, white European, African and Afro‐Caribbean, South East Asia all being treated for glaucoma at Moorfields Eye Hospital (UK). |
| Interventions |
A single per operative application of a sponge soaked in either saline or 50 mg/mL 5‐FU for 5 minutes to bare sclera before elevation of the scleral flap. All conjunctival flaps were limbus based. |
| Outcomes |
Included IOP control at 12 months according to success criteria, mean IOP in either group as well as complications. Other outcomes included visual field progression. |
| Notes |
This trial has not yet been published though it was concluded in 2002. Information was obtained from communication with the lead researchers. Funded by the Medical Research Council (UK). The authors did not include a statement about declarations of interest. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomised allocation sequence was generated by pharmacy with pre‐prepared vials of 5‐FU or placebo saline. Information obtained through communication with the lead researchers. |
| Allocation concealment (selection bias) |
Low risk |
Both surgeon and patient were masked to treatment status and both active and control fluids are identical, odourless and colourless. Information obtained through communication with the lead researchers. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐masked trial with no evidence of unmasking. Information obtained through communication with the lead researchers. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Consort diagram shows no risk of attrition bias. Information obtained through communication with the lead researchers. |
| Selective reporting (reporting bias) |
Low risk |
Medical Research Council funded RCT with an approved a priori statistical analysis. Information obtained through communication with the lead researchers. |
