Mahdy 2010.
Methods | Parallel group randomised controlled trial 1 eye per patient, unclear how eye selected Date conducted: March 2008 to December 2009 |
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Participants | Setting: hospital in Egypt Participants: 48 (31 male, 17 female), average age 44 years Inclusion criteria: clinical signs of fungal keratitis Exclusion criteria: not specified |
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Interventions |
Topical amphotericin B (Fungizone, Squib) eye drops were prepared from the commercially available 50 mg vial with 5% dextrose dilution to get the 0.05% concentration required. These were used every 2 hours for both groups. In addition to this, one group also received a 1 mL subconjunctival injection prepared directly from the commercially available intravenous infusion form of fluconazole solution (Diflucan, Pfizer), which was injected daily for the first 10 injections and every 48 hours for a further 10 injections. For both groups, in addition to the use of antifungal agents, topical atropine sulphate 1% drops were given 3 times daily and gatifloxacin 0.3% eye drops 5 times daily in cases of negative bacterial results, using specific antibacterial drops according to the sensitivity reaction of bacterial culture. The ulcers were also regularly debrided using a sharp corneal keratome (every 48 hours). |
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Outcomes |
Follow‐up 3 months |
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Notes | Funding: not reported Conflict of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “The study is a prospective, randomized one,..” Page 282 “Eyes with similar clinical and laboratory findings were classified into 2 groups of treatment.” Page 282 |
Allocation concealment (selection bias) | High risk | No description on method of allocation concealment however the study groups were exactly matched for fungal species (table 2) which is unlikely on this number of patients if the allocation was truly random |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not masked |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not masked |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Unclear risk | Difficult to judge from report |