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

Javadi 2010.

Methods Single‐centre
Parallel‐group RCT, 1 eye per person included
Participants Country: Iran
Number of participants: 43
Average age (range): 34 years (17 to 59)
Sex: 49% women
Inclusion criteria:
People who had at least 1 episode of graft rejection after penetrating keratoplasty. Graft rejection reaction was defined as "the presence of subepithelial infiltration, the presence of keratic precipitates with or without anterior chamber reaction, or graft oedema in a previously clear graft with or without keratic precipitates or anterior chamber reaction. In the case of graft oedema without keratic precipitates or anterior chamber reaction, oedema reversal after taking corticosteroids differentiated graft rejection from endothelial decompensation".
Exclusion criteria:
  • other ocular pathologies that could increase the risk of graft rejection and failure

    • iridocorneal adhesion

    • corneal vascularisation

    • previous graft failure

    • high intraocular pressure

    • uveitis

    • herpetic eye disease

Interventions Intervention:
  • CsA (topical) 2% prepared in olive oil (n = 22)


Comparator:
  • Placebo (olive oil) (n = 21)


Upon graft rejection, the participants were given CsA or placebo 4 times a day for 6 months in addition to corticosteroid treatment. Based on the severity of graft rejection reaction, corticosteroid treatment consisted of 0.1% topical betamethasone every 1 hour during waking hours with its ophthalmic ointment during sleep, alone or in combination with 1 mg/kg oral prednisolone for 2 weeks. The topical corticosteroid was gradually tapered off over 2 weeks after resolution of the rejection episode, which was defined as complete clearance of keratic precipitates or anterior chamber reaction, or both. Graft rejection episodes recurring after the termination of CsA were treated with corticosteroids as usual.
Outcomes
  1. Previous, concurrent, and subsequent numbers of rejection episodes

  2. Duration of corticosteroid administration and time to resolution of the rejection episode for which 2% topical CsA or placebo was started

  3. Time interval from the initiation of study to the first recurrence of subepithelial or endothelial graft rejection

Method and times of measuring the outcomes The participants were followed up every week until complete resolution of the graft rejection episode and then every month for 3 months, every 2 months for 1 year, and every 6 months onwards. In the case of visual acuity reduction or eye redness, participants had access to the ophthalmologist; participants were examined between the follow‐up examinations as necessary.
Funding source and statement of interest Funded by Sina Daru Pharmacy Co, Tehran, Iran.
Competing interests: Author Ahmad Karbasian is the executive manager of Sina Daru Pharmacy Co, from which 2% topical CsA and placebo were procurred. The other authors had no financial or propriety interest in any of the materials used in this study.
Notes Date study conducted: not reported
Trial registration number: NCT01028443
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomised, double‐blind clinical trial" was mentioned, but lack of detailed information.
Allocation concealment (selection bias) Unclear risk Allocation concealment was not mentioned.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Both the participants and the ophthalmologist were masked.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Only one participant was excluded, because of intolerance to the medication given.
Selective reporting (reporting bias) Unclear risk Not mentioned.
Other bias Unclear risk Not mentioned.