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

Rahman 1997.

Methods Parallel group randomised controlled trial
People enrolled and randomly allocated, number of eyes not reported
Date conducted: not reported
Participants Setting: Aravind Eye Hospital in Madurai, India
Participants: 60 (46 men, 14 women estimated from data on subgroup) average age not reported
Inclusion criteria: suppurative corneal ulcer with fungal elements demonstrated in a potassium hydroxide preparation and culture, agree to stay in hospital at 7 days and return at 21 days
Exclusion criteria: only 1 eye, children under 1 year, diabetics, perforated corneal ulcer, mixed bacterial and fungal infections
 Male (76%), aged 50 years and above (33%)
Interventions
  • Chlorhexidine gluconate 0.05% (N = 8)

  • Chlorhexidine gluconate 0.1% (N = 17)

  • Chlorhexidine gluconate 0.2% (N = 17)

  • Natamycin 5% (N = 18)


One drop was applied every half hour for 3 hours, then once every hour during waking hours. From the second day, the drop was applied every 2 hours for 5 days, and then every 3 hours for a further 2 weeks. If there was no improvement by 5 days the code was broken and an alternative treatment used. People in the chlorhexidine groups were given natamycin, people in the natamycin group were given econazole 1%.
Outcomes
  • Favourable response at 5 days (defined as relief from symptoms such as pain and watering, improvement in at least 1 of the following signs: reduction of inflammation, reduction in cellular infiltrate and oedema, reduction in measured corneal epithelial defect, signs of re‐epithelialisation, reduction in anterior chamber hypopyon if present)

  • Cure by day 21 (defined as intact epithelium, with or without scar formation, but no perforation, anterior staphyloma, no adherent leukoma, no fluorescein staining, no hypopyon and improvement of vision or vision no worse than baseline)

  • Toxicity (defined as patient's intolerance indicated by pain or burning sensation, swelling of eyelids, increased conjunctival congestion and chemosis, conjunctival staining with fluorescein, punctate corneal epithelial erosion)


Follow‐up: 3 weeks
Notes Funding: British Council for the Prevention of Blindness
Conflict of interest: not reported
12 patients with severe ulcers were excluded in the analysis of outcome at 21 days since only 1 (from chlorhexidine gluconate 0.05%) had favourable response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomization was computer generated by statisticians at Aravind, using the one‐sample run test.” Page 143
Allocation concealment (selection bias) Low risk “… 60 consecutive patients were randomly allocated in a double‐masked fashion..” Page 142
The bottles were prepared and labelled only with the randomized numbers by the Aravind executive staff” Page 143
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk “… 60 consecutive patients were randomly allocated in a double‐masked fashion..” Page 142
The bottles were prepared and labelled only with the randomized numbers by the Aravind executive staffPage 143
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk … 60 consecutive patients were randomly allocated in a double‐masked fashion..” Page 142
The bottles were prepared and labelled only with the randomized numbers by the Aravind executive staff” Page 143
  
But for “treatment failures” the code was broken on day 5 so presumably all assessments after that date were unmasked
Incomplete outcome data (attrition bias) 
 All outcomes Low risk "Two patients were lost to follow‐up, so that 58 patients were left in the study" Page 144
Selective reporting (reporting bias) Unclear risk A number of different outcome measures reported and no indication as to whether these were all outcomes on which data collected