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. 2015 Apr 9;2015(4):CD004241. doi: 10.1002/14651858.CD004241.pub4

Prajna 2003.

Methods Parallel group randomised controlled trial
1 eye per patient, unclear how eye selected
 Date conducted: March 2002 to October 2002
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
Interventions
  • Topical econazole 2%

  • Topical natamycin 5%


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.
Outcomes
  • Healed ulcer (defined as completely healed epithelial defect with no fluorescein staining, non‐progression of stromal infiltration)


Follow‐up: 4 weeks
Notes Funding: Aravind Medica Research Foundation
Conflict of interest: reported "none"
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