Rajak 2011a.
Methods | Study Design: parallel group randomised trial of epilation versus surgery for minor trichiasis. Non‐inferiority trial. 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: 81 Male: 537, Female: 863 Minor trichiasis cases only |
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Interventions | (1) Posterior lamellar tarsal rotation (2) Epilation with new forceps and training |
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Outcomes | Primary Outcome: proportion of individuals at any follow‐up who had “failed” defined as either (1) five or more eyelashes touching the globe or (2) a history of surgery performed in the trial eye at any point during the follow‐up period (in the case of the surgical arm this would be repeat surgery). A pre‐specified non‐inferiority margin was 10%. 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. Tweezerman donated all forceps. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "Participants were randomly allocated to the epilation or surgery groups 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 intersurgeon 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 colour coded for surgeon and placed in separate containers for each surgeon. The person who prepared these envelopes was independent of all other aspects of the trial." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were not masked to their allocation, as they either received surgery or practiced epilation. Other than the surgeons performing the operation and the epilation trainer, all other personnel were masked to the allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote "The two individuals responsible for all the clinical outcome measurements were masked to the allocation. At follow‐up, the trichiasis and corneal examination was performed and recorded before the eyelid was everted, so that the examiner was masked to whether surgery had been performed on the tarsal conjunctiva." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 93.5% follow‐up at 24 months. |
Selective reporting (reporting bias) | Low risk | Study protocol published online. |