Burton 2005a.
| Methods | Study Design: parallel group randomised trial of peri‐operative azithromycin treatment Eyes: only one eye per participant was included in the analysis. In bilateral cases, the eye with more severe baseline trichiasis was included. |
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| Participants | Country: The Gambia Setting: health centres Number of participants: 451 Lost to follow up: 25 Male: 133, Female: 318 A consecutive, geographically defined sub‐set of the original participants was followed‐up at 4 years. Number of participants: 356 Lost to follow up: 90 Male: 103, Female: 253 Major trichiasis cases only |
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| Interventions | (1) Posterior lamellar tarsal rotation surgery (no placebo) (2) Posterior lamellar tarsal rotation surgery followed by single‐dose azithromycin treatment at baseline and 6 months, administered to the patient and the members of their household | |
| Outcomes | Primary Outcome: recurrent trichiasis by one year Secondary Outcomes: visual acuity by reduced LogMAR chart, conjunctival infection, corneal opacification Follow up: 12 months and 4 years (subset) |
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| Notes | Funder: International Trachoma Initiative | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote "Separate randomisation sequences were generated for each surgeon from random number tables and blocked in groups of four" |
| Allocation concealment (selection bias) | Low risk | Quote "Treatment allocations were concealed in opaque sequentially numbered envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote "Immediately following surgery a nurse not involved in clinical assessments or surgery administered the randomly allocated treatment." Participants were not masked to allocation, as no placebo was used. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote "Examiners were ‘‘blinded’’ to treatment allocation." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 98% follow‐up of those still alive at 1 year. At 4 years 94% of the surviving patients were re‐examined |
| Selective reporting (reporting bias) | Low risk | Clear analytical approach in methods. |