Mathew 2003.
| Methods | Randomized controlled trial Ethics committee approval; informed consents obtained | |
| Participants | 119 patients undergoing elective clear corneal phacoemulsification Inclusion criterion: patient listed for cataract surgery Exclusion criterion: none stated Study demographics: 17 men in topical anaesthesia, 8 in sub‐Tenon's; 29 women in topical anaesthesia, 15 in sub‐Tenon's Mean age (years) in topical anaesthesia: 76.4, sub‐Tenon's: 75.9. Age range (years) in topical anaesthesia was 46 to 93 years, in sub‐Tenon's, range was 54 to 92 years |
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| Interventions | Treatment group:: proparacaine 0.5% (n = 46) Control group: sub‐Tenon’s anaesthesia without IV cannula insertion (n = 23) was provided by a single consultant (L.E.). Two other consultants (S.B.M., H.G.B.B.) used sub‐Tenon’s anaesthesia with IV cannula insertion (n = 50): Lignocaine 2% + bupivacaine 0.5% or 0.75% + hyaluronidase 3 to 5 mL. All participants received diclofenac sodium 0.1% (Voltarol), 2 drops every 20 minutes 2 times; phenylephrine hydrochloride 2.5% (Minims), 1 drop every 5 minutes 3 times; and cyclopentolate 1% (Minims), 1 drop every 5 minutes 3 times, beginning 45 minutes before the procedure. No intracameral anaesthesia was used intraoperatively. | |
| Outcomes | Pain felt on administration of anaesthesia Pain felt intraoperatively (mean) | |
| Notes | Complications not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Method not stated. Three groups with unequal numbers. Diffferent surgeon for each group |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were randomly assigned to 1 of the sub‐Tenon’s anaesthesia groups and were informed about which type of local anaesthesia they were to receive |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Two patients were excluded from the study for incomplete data entry" |
| Selective reporting (reporting bias) | High risk | Not in intention‐to‐treat: "Two patients were excluded from the study for incomplete data entry" |
| Other bias | Low risk | Groups well balanced |