Rajak 2011b.
Methods | Study Design: parallel group randomised trial of absorbable versus silk sutures for major trichiasis. Eyes: only one eye per participant was included in the analysis. In bilateral cases, one eye was randomly assigned to be the 'study eye', although both eyes were treated, if indicated. |
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Participants | Country: Ethiopia Setting: health centres Number of participants: 1300 Lost to follow up: 82 Male: 285, Female: 1015 |
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Interventions | (1) Posterior lamellar tarsal rotation with absorbable sutures (2) Posterior lamellar tarsal rotation with silk sutures |
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Outcomes | Primary Outcome: proportion of those individuals seen at the 12‐month follow‐up who were found to have either (1) recurrent trichiasis, defined as one or more lashes touching the eye or clinical evidence of epilation; or (2) a history of repeat TT surgery during the first year. Secondary Outcomes: corneal opacity change, visual acuity by LogMAR E‐chart, entropion, conjunctival inflammation and symptoms by questionnaire. Follow up at 6, 12, 18 and 24 months. |
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Notes | Funder: Band Aid Foundation and The Wellcome Trust. Johnson & Johnson donated all sutures. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "Participants were randomly allocated to the silk or polyglactin‐910 suture arms using a 1:1 allocation ratio for each surgeon, using a computer‐generated randomisation sequence with random block sizes. Randomisation was stratified by surgeon because of possible inter‐surgeon variability." |
Allocation concealment (selection bias) | Low risk | Quote "The random allocation sequences for each surgeon were concealed in sequentially numbered, sealed, opaque envelopes, which were placed in separate containers for each surgeon; a person independent of all other aspects of the trial prepared these envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote "Participants and surgeons were aware of the suture allocation." Other personnel involved in the study were masked to the allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote "The two individuals who were responsible for all the clinical observations in this trial were masked to the allocation." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 95.1% follow‐up at 12 months. |
Selective reporting (reporting bias) | Low risk | Study protocol published online. |