Prajna 2003.
Methods | Parallel group randomised controlled trial 1 eye per patient, unclear how eye selected Date conducted: March 2002 to October 2002 |
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Participants | Setting: Aravind, India
Participants: 116 (72 men, 44 women), average age 37 years Inclusion criteria: smear and culture positive for fungal infection; ulcer at least 2 mm2 and not more than 60 mm2 Exclusion criteria: did not consent to study |
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Interventions |
Participants were admitted to the hospital for a week. Interventions were applied every hour between 7am and 9pm. 1% atropine sulphate ointment was applied 3 times per day in the affected eye at least 15 minutes after application of the antifungal eye drops. |
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Outcomes |
Follow‐up: 4 weeks |
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Notes | Funding: Aravind Medica Research Foundation Conflict of interest: reported "none" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “…subjects were randomized to receive either…” Page 1235 |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | “Since natamycin is available as a suspension, and precipitates in the corneal tissue, it was not possible to mask the investigator to the drugs used on subsequent visits.” Page 1235 |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | “Since natamycin is available as a suspension, and precipitates in the corneal tissue, it was not possible to mask the investigator to the drugs used on subsequent visits.” Page 1235 |
Incomplete outcome data (attrition bias) All outcomes | High risk | “Four of the 116 patients randomized at baseline did not return for further follow‐up (Fig 1) and were dropped from the study.” Page 1236 However, this contradicts figure 1 where 5 people were lost to follow‐up by week 4. Also large numbers of people “exited” the study due to clinical worsening or reaction to drops. By week 4, 25/61 in the econazole group and 22/55 of natamycin group remained in the study |
Selective reporting (reporting bias) | Low risk | Reported “time to cure” and no indication of any unreported variables |