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Study Title and Description

The effect of Nd:YAG laser iridotomy on pigmentary glaucoma patients: a prospective study



Key Questions Addressed
1 What is the effect of peripheral iridotomy for pigmentary glaucoma?
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Primary Publication Information
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TitleData
Title The effect of Nd:YAG laser iridotomy on pigmentary glaucoma patients: a prospective study
Author Costa VP, Gandham S, Spaeth GL, Moster MR, Katz LJ, Wilson RP, et al
Country
Year 1994
Numbers

Secondary Publication Information
UI Title Author Country Year
The effects of peripheral iridectomy on pigmentary glaucoma [O efeito da iridectomia periférica em pacientes com glaucoma pigmentar] Costa VP, Gandham S, Smith M, Spaeth GL 1994
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The effect of peripheral iridotomy on pigmentary glaucoma Spaeth GL, Moster MR, Mansukani S, Gandham S, Ruskovic D, Affel L, et al 1995
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Extraction Form: Peripheral iridotomy for pigmentary glaucoma 2016
Arms
Number Title Description Comments
1 Peripheral laser iridotomy iridotomy using a neodymium:yttrium–aluminum–garnet (Nd:YAG) laser
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2 Anti-glaucoma medications anti-glaucoma medications in a predetermined order of pilocarpine 1%, beta blockers, and carbonic anhydrase inhibitors
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Design Details
Question... Follow Up Answer Follow-up Answer
Study design parallel-group, randomized controlled trial
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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
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Exclusions after randomization none reported
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Losses to follow-up none reported
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Number analyzed 14 eyes of 14 participants: 9 eyes of 9 participants in laser group and 5 eyes of 5 participants in control group
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Unit of analysis participant (1 eye per participant)
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Handling of missing data not applicable
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Sample size and power calculation not reported
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Country not reported
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Mean age 49 years (range not reported) in the laser group; 47 years (range not reported) in the control group
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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)
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Inclusion criteria pigmentary glaucoma
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Exclusion criteria previous intraocular surgery
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Equivalence of baseline characteristics not reported
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Laser iridotomy using a neodymium:yttrium–aluminum–garnet (Nd:YAG) laser
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Control anti-glaucoma medications in a predetermined order of pilocarpine 1%, beta blockers, and carbonic anhydrase inhibitors
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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
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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)
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Intervals at which outcomes assessed 1, 3, 6 months, and 2 years
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Information on cost of interventions or quality of life none reported
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Study period not reported
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Trial registration none reported
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Source of funding not reported
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Disclosures of interest not reported
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Subgroup analyses none reported
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Random sequence generation (selection bias):Authors' judgement Unclear risk
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Random sequence generation (selection bias):Support for judgement Method of randomization not reported.
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Allocation concealment (selection bias):Authors' judgement Unclear risk
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Allocation concealment (selection bias):Support for judgement Method of allocation concealment not reported.
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Masking of outcome assessors (detection bias)Visual field:Authors' judgement Unclear risk
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Masking of outcome assessors (detection bias)Visual field:Support for judgement Visual field not reported as an outcome.
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Masking of outcome assessors (detection bias)Intraocular pressure:Authors' judgement Unclear risk
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Masking of outcome assessors (detection bias)Intraocular pressure:Support for judgement Masking of IOP assessors not reported.
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Incomplete outcome data (attrition bias):Authors' judgement Low risk
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Incomplete outcome data (attrition bias):Support for judgement Investigators reported no participants were lost to follow-up
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Selective reporting (reporting bias):Authors' judgement Unclear risk
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Selective reporting (reporting bias):Support for judgement 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
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Other bias:Authors' judgement Low risk
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Other bias:Support for judgement None identified
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Results & Comparisons


Results Data
Outcome: Mean change in IOP from baseline      Population: All Participants
Time Point Measure Peripheral laser iridotomy Anti-glaucoma medications


8-10 months

N Analyzed 9 5
Mean -0.44 2.25
SD 4.61 1.70
Outcome: Visual acuity      Population: All Participants
Time Point Measure Peripheral laser iridotomy Anti-glaucoma medications


8-10 months

N Analyzed 9; reported only that visual acuity did not significantly differ between groups 5; reported only that visual acuity did not significantly differ between groups
Outcome: Change in anterior chamber depth      Population: All Participants
Time Point Measure Peripheral laser iridotomy Anti-glaucoma medications


8-10 months

N Analyzed 9 5
Mean 0 -0.04
SD 0.07 0.11
Outcome: Pigment accumulation in the trabecular meshwork      Population: All Participants
Time Point Measure Peripheral laser iridotomy Anti-glaucoma medications


8-10 months

N Analyzed 9 5
Mean -0.22 0.10
SD 0.44 0.22

Adverse Events
Arm or Total Title Description Proportion of adverse events Comments
Peripheral laser iridotomy Any adverse event Not reported
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Anti-glaucoma medications
Total