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 |
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 |
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 staff” Page 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 |