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

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
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.
Interventions
  • Topical 1% itraconazole (N = 27)

  • Topical 1% itraconazole and oral itraconazole (N = 27)


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.
Outcomes
  • "Responded" to treatment (but response not defined)

  • Graded according to change in visual acuity and residual corneal opacity

  • Adverse events: oedema, increased intraocular pressure and congestion were reported if present


Follow‐up: 6 months
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.
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