Sekundo 2004.
| Methods | Randomized controlled trial Consents obtained | |
| Participants | 100 participants listed for cataract surgery on single eye Exclusion criteria: mature cataracts, deafness, glaucoma, astigmatism > 1D, mental incapacity to understand task, colour blindness, younger than 30 years of age Study participants: 100 were enrolled for single eye surgery: 50 to topical anaesthesia, 50 to sub‐Tenon's. 5 (topical anaesthesia) were excluded for intense pain Study demographics: 10 men under topical anaesthesia, 14 under sub‐Tenon's; 40 women under topical anaesthesia, 36 under sub‐Tenon's. Mean age (years) in topical anaesthesia group 72.6, sub‐Tenon's group 73.5. Age range was not stated | |
| Interventions |
Treatment group: Topical anaesthesia with oxybuprocaine 0.4% 1 drop, xylocaine 2% jelly, 2 applications over 7 to 10 minutes, lignocaine 1% 1 drop on bare sclera, lignocaine 1% 0.5 mL intracamerally (n = 50)
Control group: sub‐Tenon's anaesthesia with oxybuprocaine 0.4% 1 drop topically, xylocaine 2% 2 mL
Surgical technique: standard divide and conquer phacoemulsification via a sclerocorneal self sealing tunnel at 12 o’clock, with implantation of a 6 mm polymethylmethacrylate intraocular lens. Surgery started immediately after withdrawal of the cannula (n = 50) All surgeries performed by the same surgeon Oral sedative: midazolam 3.75 mg orally |
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| Outcomes | Pain felt intraoperatively (this score included the anaesthetic technique), measured on a 10‐point VAS scale Pain assessed: immediately after surgery | |
| Notes | No intraoperative complications occurred in any of the study groups. One case of postoperative iritis (cells and flare in the anterior chamber) was encountered in each group postoperatively. Both cases resolved with intensified topical steroids without sequelae | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly assigned"; no details |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Surgeon not blinded; unclear for participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Independent investigator |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | Intention‐to‐treat for pain scores |
| Other bias | Low risk | Groups well balanced |