Agarwal 2001.
Methods | Cross‐over randomised controlled trial People enrolled and randomly allocated, number of eyes not reported Date conducted: June 1999 to September 2000 |
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Participants | Setting: Calcutta, India Participants: 54 (37 men, 17 women), average age 35 years (estimated from Table 1) Inclusion criteria: "Clinically suspected cases of fungal corneal ulcers" Exclusion criteria: not specified Participants were divided into 2 groups. Group I comprised new patients and Group II comprised patients who had been previously treated with agents. |
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Interventions |
Topical itraconazole was prepared by mixing 100 mg of itraconazole powder with 100 mL of artificial tear solution under sterile conditions. Oral itraconazole 100 mg was given twice daily for 3 weeks along with topical itraconazole every hour. The topical itraconazole was applied for 6 weeks after the ulcer healed. Cycloplegics were used in all cases. Antiglaucoma therapy was given in cases suspected to have raised intraocular pressure. Antibacterials (topical ciprofloxacin) were applied in all cases at the beginning of treatment but stopped once fungal aetiology confirmed. |
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Outcomes |
Follow‐up: 6 months |
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Notes | Funding: not reported Conflict of interest: not reported Although trial report states this was a cross‐over trial it was not clear from the study report that it actually was. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The patients were divided into two groups" on the basis of new and untreated patients but no other information is given |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported but treatments different |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported but treatments different |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not possible to assess |
Selective reporting (reporting bias) | Unclear risk | Not possible to assess |