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. 2015 Aug 27;2015(8):CD007603. doi: 10.1002/14651858.CD007603.pub2

Zhang 2009.

Methods Multicentre (4 centres)
Parallel‐group RCT, unclear how many eyes included
Participants Country: China
Number of participants: 240
Average age (range): 18 to 65 years
Sex: F/M: 36/84 and 27/93, respectively
High‐risk keratoplasty
Interventions Intervention:

  • CsA (topical) 1% (n = 120)


Comparator:

  • Placebo (n = 120)


CsA given as eye drops 4 ˜ 6 times a day, 2 drops a time, total 6 months. In both groups, 1% dexamethasone eye drops 4 times a day, 1 ˜ 2 drops a time. 2 weeks later 3 times a day, 30 days later 2 times a day, 2 months later 1 time a day.
Outcomes Primary outcomes:

  1. Clarity of the corneal graft, with no ciliary congestion, clear corneal graft, normal thickness was rated as effective

  2. Rejection rate and time of onset of rejection


Secondary outcomes:

  1. Result of treatment for rejection

  2. Adverse effects
Method and times of measuring the outcomes Follow‐up over 180 days.
Funding source and statement of interest The funding source was not mentioned, but two of the authors came from the Huabei Pharmaceutical Group New Drug Development LTD., where the experimental drug is made.
The declaration of interest was not provided.
Notes Date study conducted: not reported. We telephoned the first author, Professor Zhang, and known that the study was conducted between July, 2003 to August, 2004.
Trial registration number: not registered
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table was mentioned, but procedure not described in detail.
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 All outcomes Low risk Placebo used and adequately masked.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Treatment not completed in 1 case in the CsA group (1/120) and 9 cases in the control group (9/120).
Selective reporting (reporting bias) Unclear risk No information.
Other bias Unclear risk No information.

CsA: cyclosporine A
 MMF: mycophenolate mofetil
 RCT: randomised controlled trial
 SD: standard deviation