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. 2016 Feb 12;2016(2):CD005655. doi: 10.1002/14651858.CD005655.pub2

Costa 1994.

Study characteristics
Methods Study design: parallel‐group, randomized controlled trial
Number randomly assigned: 14 eyes of 14 participants: 9 eyes of 9 participants to laser group and 5 eyes of 5 participants to control group
Exclusions after randomization: none reported
Losses to follow‐up: none reported
Number analyzed: 14 eyes of 14 participants: 9 eyes of 9 participants in laser group and 5 eyes of 5 participants in control group
Unit of analysis: participant (1 eye per participant)
Handling of missing data: not applicable
Sample size and power calculation: not reported
Participants Country: not reported
Mean age: 49 years (range not reported) in the laser group; 47 years (range not reported) in the control group
Gender: 7 (78%) men and 2 (22%) women in the laser group; 6 (86%) men and 1 (14%) woman in the control group (potential error in reporting, control group does not add up to 5 participants)
Inclusion criteria: pigmentary glaucoma
Exclusion criteria: previous intraocular surgery
Equivalence of baseline characteristics: not reported
Interventions Laser: iridotomy using a neodymium:yttrium–aluminum–garnet (Nd:YAG) laser
Control: anti‐glaucoma medications in a predetermined order of pilocarpine 1%, beta blockers, and carbonic anhydrase inhibitors
Length of follow‐up:
Planned: up to 6 months, with extended follow‐up at 2 years
Actual: unclear; mean follow‐up was 8 months in the laser group and 10 months in the control group
Outcomes Outcomes (primary and secondary outcomes not differentiated): visual acuity, mean change in IOP, mean changes in graded pigment dispersion indices (iris transillumination, Krukenberg spindles, trabecular meshwork pigmentation), and mean changes in anterior segment measures (chamber depth and angle)
Intervals at which outcomes assessed: 1, 3, 6 months, and 2 years
Information on cost of interventions or quality of life: none reported
Notes Study period: not reported
Trial registration: none reported
Source of funding: not reported
Disclosures of interest: not reported
Subgroup analyses: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomization not reported.
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not reported.
Masking of outcome assessors (detection bias)
Visual field Unclear risk Visual field not reported as an outcome.
Masking of outcome assessors (detection bias)
Intraocular pressure Unclear risk Masking of IOP assessors not reported.
Incomplete outcome data (attrition bias)
All outcomes Low risk Investigators reported no participants were lost to follow‐up
Selective reporting (reporting bias) Unclear risk No protocol or clinical trial registration record was available to assess selective outcome reporting. All outcomes mentioned in the Methods section of the published paper were reported in the Results section
Other bias Low risk None identified