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

Mahdy 2010.

Methods Parallel group randomised controlled trial
1 eye per patient, unclear how eye selected
Date conducted: March 2008 to December 2009
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
Interventions
  • Topical amphotericin B 0.05% and subconjunctival fluconazole 0.2% (N = 24)

  • Topical amphotericin B 0.05% alone (24 eyes)


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).
Outcomes
  • Healing of corneal ulcer

  • Mean best corrected visual acuity (Landolt chart)


Follow‐up 3 months
Notes Funding: not reported
Conflict of interest: not reported
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