Advanced Search

Study Preview



Study Title and Description

Laser iridotomy versus low dose pilocarpine treatment in patients with pigmentary glaucoma



Key Questions Addressed
1 What is the effect of peripheral iridotomy for pigmentary glaucoma?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Laser iridotomy versus low dose pilocarpine treatment in patients with pigmentary glaucoma
Author Georgopoulos GT, Papaconstantinou DS, Patsea LE, Andreanos DG, Vergados J, Chalkiadakis J, et al
Country
Year 2001
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


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
  • Comments Comments (
    0
    ) |
2 Pilocarpine 2% pilocarpine 2% drops 1 or 2 times daily
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study design paired-eye, randomized controlled trial
  • Comments Comments (
    0
    ) |
Number randomly assigned 46 eyes of 23 participants; the fellow eye of each participant was the control
  • Comments Comments (
    0
    ) |
Exclusions after randomization not reported
  • Comments Comments (
    0
    ) |
Losses to follow-up not reported
  • Comments Comments (
    0
    ) |
Number analyzed not reported, but "in 6 patients UBM study was available for pre- and post-treatment evaluation"
  • Comments Comments (
    0
    ) |
Unit of analysis eye (both eyes per participant)
  • Comments Comments (
    0
    ) |
Handling of missing data not reported
  • Comments Comments (
    0
    ) |
Sample size and power calculation none reported
  • Comments Comments (
    0
    ) |
Country not reported
  • Comments Comments (
    0
    ) |
Mean age 28 years (range 20 to 45 years); not reported by group
  • Comments Comments (
    0
    ) |
Gender 17 (74%) men and 6 (26%) women; not reported by group
  • Comments Comments (
    0
    ) |
Inclusion criteria clinically diagnosed pigmentary glaucoma in both eyes
  • Comments Comments (
    0
    ) |
Exclusion criteria not reported
  • Comments Comments (
    0
    ) |
Equivalence of baseline characteristics yes
  • Comments Comments (
    0
    ) |
Laser iridotomy using a neodymium:yttrium–aluminum–garnet (Nd:YAG) laser
  • Comments Comments (
    0
    ) |
Control pilocarpine 2% drops 1 or 2 times daily
  • Comments Comments (
    0
    ) |
Length of follow-up Planned: not reported Actual: ranged from 6 to 23 months
  • Comments Comments (
    0
    ) |
Outcomes (primary and secondary outcomes not differentiated); uncontrolled IOP, defined as the proportion of participants who needed additional treatment for control of IOP (IOP > 21 mmHg), change in iris configuration measured by UBM
  • Comments Comments (
    0
    ) |
Intervals at which outcomes assessed not reported
  • Comments Comments (
    0
    ) |
Information on cost of interventions or quality of life none reported
  • Comments Comments (
    0
    ) |
Study period not reported
  • Comments Comments (
    0
    ) |
Trial registration none reported
  • Comments Comments (
    0
    ) |
Source of funding not reported
  • Comments Comments (
    0
    ) |
Disclosures of interest not reported
  • Comments Comments (
    0
    ) |
Subgroup analyses Changes in iris configuration were assessed in 12 eyes of 6 participants only; trial authors did not report reasons for inclusion or exclusion in subgroup analysis
  • Comments Comments (
    0
    ) |
Random sequence generation (selection bias):Authors' judgement Unclear risk
  • Comments Comments (
    0
    ) |
Random sequence generation (selection bias):Support for judgement Method of randomization not reported
  • Comments Comments (
    0
    ) |
Allocation concealment (selection bias):Authors' judgement Unclear risk
  • Comments Comments (
    0
    ) |
Allocation concealment (selection bias):Support for judgement Method of allocation concealment not reported
  • Comments Comments (
    0
    ) |
Masking of outcome assessors (detection bias)Visual field:Authors' judgement Unclear risk
  • Comments Comments (
    0
    ) |
Masking of outcome assessors (detection bias)Visual field:Support for judgement Visual field not reported as an outcome
  • Comments Comments (
    0
    ) |
Masking of outcome assessors (detection bias)Intraocular pressure:Authors' judgement Unclear risk
  • Comments Comments (
    0
    ) |
Masking of outcome assessors (detection bias)Intraocular pressure:Support for judgement Masking of IOP assessors not reported
  • Comments Comments (
    0
    ) |
Incomplete outcome data (attrition bias):Authors' judgement High risk
  • Comments Comments (
    0
    ) |
Incomplete outcome data (attrition bias):Support for judgement Number of participants analyzed not reported for IOP outcomes. "In 6 patients UBM study was available for pre- and post-treatment evaluation"; it was not clear why only 6/23 participants were part of the UBM study
  • Comments Comments (
    0
    ) |
Selective reporting (reporting bias):Authors' judgement Unclear risk
  • Comments Comments (
    0
    ) |
Selective reporting (reporting bias):Support for judgement All outcomes mentioned in the Methods section of the conference abstract were reported in the Results section
  • Comments Comments (
    0
    ) |
Other bias:Authors' judgement Low risk
  • Comments Comments (
    0
    ) |
Other bias:Support for judgement None identified
  • Comments Comments (
    0
    ) |




Results & Comparisons


Results Data
Outcome: Iris configuration      Population: All Participants
Time Point Measure Peripheral laser iridotomy Pilocarpine 2%


6-23 months

N Analyzed 6/6 eyes showed flattening compared with baseline 6/6 eyes showed a more concave configuration compared with baseline
Outcome: Need for additional topical medication      Population: All Participants
Time Point Measure Peripheral laser iridotomy Pilocarpine 2%


6-23 months

N Analyzed 23 23
Counts 19 11
Outcome: Intraocular pressure      Population: All Participants
Time Point Measure Peripheral laser iridotomy Pilocarpine 2%


6-23 months

N Analyzed
Mean
SD
SE

Adverse Events
Arm or Total Title Description Proportion of adverse events Comments
Peripheral laser iridotomy Anyy adverse event Not reported
  • Comments Comments (
    0
    ) |
Pilocarpine 2%
Total