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. 2019 Apr 19;2019(4):CD011875. doi: 10.1002/14651858.CD011875.pub2

Kalenak 1996.

Methods Study design: parallel group, randomized controlled trial
Number randomized: 25 eyes of 25 participants
Exclusions after randomization: none reported
Number analyzed: 25 eyes of 25 participants
Unit of analysis: participant (one study eye per participant)
Handling of missing data: none reported
Sample size calculation: not reported
Participants Country: USA
Mean age: not reported
Gender: not reported
Inclusion criteria: glaucoma with inadequately controlled IOP; at least one previous glaucoma filtering operation
Exclusion criteria: neovascular glaucoma
Equivalence of baseline characteristics: not reported
Diagnoses in participants: non‐neovascular glaucoma
Interventions MMC group (n = 12): single‐plate Molteno implant with MMC (0.2 mg/mL)
No MMC group (n = 13): single‐plate Molteno implant with placebo for 5 minutes
Outcomes Outcomes (primary and secondary outcomes not differentiated): mean IOP; surgical success, defined as IOP between 6 and 21 mmHg
Length of follow‐up: "6 months or more, or to a defined endpoint"
Notes Study period: not reported
Trial registration: not reported
Funding and conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not reported
Allocation concealment (selection bias) Unclear risk Allocation concealment not reported
Masking of participants and personnel (performance bias) Unclear risk Masking of participants and personnel not reported
Masking of outcome assessment (detection bias) Unclear risk Masking of outcome assessors not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Missing data not reported
Selective reporting (reporting bias) High risk No full‐length paper published more than 20 years after presenting the trial at a conference
Other bias Low risk None identified