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document
Evaluation of masking study participants to intravitreal injections in a randomized clinical trial . OBJECTIVE To evaluate the success of masking study participants to treatment allocation using sham intravitreal injections . METHODS Eyes were randomized to receive sham injections plus prompt laser , intravitreal ranibizumab injections plus prompt laser , intravitreal ranibizumab injections plus deferred laser , or intravitreal triamcinolone acetonide injections plus prompt laser up to every 16 weeks with sham injections intermittently . All eyes could receive treatment or sham as often as every 4 weeks . Participants with 2 study eyes had 1 eye randomized to sham plus prompt laser and 1 eye randomized to a real injection group . Sham injections were performed by pressing the syringe hub against the conjunctiva to mimic a real injection . Laser treatment was not masked . At the 1-year visit , participants were asked if they believed that the injections received during the study were real , sham , or sometimes real and sometimes sham . RESULTS Among 423 participants with 1 study eye , the correct assignment was stated by 9.9 % of the sham plus prompt laser group , 88.0 % of the ranibizumab plus prompt laser group , 89.6 % of the unmasked ranibizumab plus deferred laser group , and 44.0 % of the triamcinolone plus prompt laser group . Among 112 participants with 2 study eyes , the correct assignment was stated for 24.1 % of the sham plus prompt laser eyes . CONCLUSIONS Successful masking of an intravitreal injection can be accomplished when a sham injection procedure carefully mimics a real injection procedure . Masking seems less successful when one eye is receiving a real injection and the other eye is receiving a sham injection or when an individual eye receives both real and sham injections .
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Intervention_Pharmacological
sham intravitreal injections
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Intervention_Pharmacological
sham injections plus
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Intervention_Physical
prompt laser
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Intervention_Pharmacological
intravitreal ranibizumab injections plus
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Intervention_Physical
prompt laser
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Intervention_Pharmacological
intravitreal ranibizumab injections plus
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Intervention_Physical
deferred laser
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Intervention_Pharmacological
intravitreal triamcinolone acetonide injections plus
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Intervention_Physical
prompt laser
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Intervention_Physical
sham plus prompt laser
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Intervention_Pharmacological
real injection
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Intervention_Physical
Laser treatment
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Intervention_Other
sometimes real and sometimes sham
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Intervention_Physical
ranibizumab plus deferred laser
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Intervention_Pharmacological
triamcinolone plus prompt laser
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Intervention_Pharmacological
sham injection
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Intervention_Pharmacological
real injection
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Outcome_Other
success
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Outcome_Other
correct assignment
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Outcome_Other
correct assignment
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Outcome_Other
Successful masking
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Outcome_Other
Masking
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Outcome_Other
successful
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Participant_Sample-size
423
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Participant_Condition
1 study eye
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Participant_Sample-size
112
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Participant_Condition
2 study eyes