Gower 2013.
Methods | Study Design: parallel group randomised controlled trial bilamellar tarsal rotation surgery with or without a TT clamp Eyes: both eyes of bilateral cases were included in the analysis. Appropriate adjustment was made in the analysis for bilateral cases. |
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Participants | Country: Tanzania Setting: health centres Number of participants: 1917 Number of Eyes: 3345 Lost to follow up: 51 Male: 490, Female: 1427 |
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Interventions | (1) Standard bilamellar tarsal rotation (2) Bilamellar tarsal rotation performed with a TT clamp |
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Outcomes | Primary Outcome: was defined as one or more of the following: recurrent trichiasis, eyelid contour abnormality or granuloma. Secondary outcomes: post‐operative trichiasis, eyelid contour abnormality or granuloma individually. Follow‐up: 6 weeks, 12 months, 24 months. |
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Notes | 18 different surgical technicians performed the surgery. Surgeons were randomly allocated at the outset to only perform one of the two types of operation. Each recruitment day there were 4 surgical technicians operating – 2 standard procedure and 2 with the TT clamp. Patients with TT were randomly allocated to one of the 4 surgical technicians operating. Funder: Bill and Melinda Gates Foundation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "Randomization assignments were created using permuted block sizes of 6 to 12". |
Allocation concealment (selection bias) | Low risk | Quote "Randomization assignments were placed in opaque envelopes and stored in a locked office until distribution". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and surgical technicians were not masked to the allocation; however, this is unlikely to have affected the outcome measure. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote "Examinations were conducted by a single trained examiner who was not involved in enrolment, randomization, or surgical procedures". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 98% follow‐up rate. |
Selective reporting (reporting bias) | Low risk | No study protocol available. Clear analytical approach in methods. |