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. 2015 Jul 14;2015(7):CD008671. doi: 10.1002/14651858.CD008671.pub3

Gimbel 1995.

Methods Study design: parallel‐group RCT
Unit of randomization: the individual (one eye per participant)
Number randomized: 106 total; 53 eyes of 53 participants in combined surgery group and 53 eyes of 53 participants in cataract surgery alone group
Unit of analysis: the individual (one eye per participant)
Number analyzed: 102 total; 51 eyes of 51 participants in combined surgery group and 51 eyes of 51 participants in cataract surgery alone group
Exclusions and losses to follow‐up: 4 participants; 2 in each group
Power calculation: none reported
Participants Country: Canada (one site), South Africa (two sites)
Age (mean ± SD): 75.5 years in combined surgery group; 77.5 years in cataract surgery alone group (SDs not reported)
Gender: not reported
Ethnicity: not reported
Inclusion criteria:
  1. IOP ≥ 17 mmHg and < 27 mmHg on no medication or only a topical beta‐blocker

  2. visual field defects consistent with glaucomatous damage

  3. cup‐to‐disc ratio of > 0.5


Exclusion criteria:
  1. closed‐angle glaucoma

  2. post‐traumatic glaucoma

  3. neovascular glaucoma

  4. use of glaucoma medications other than topical beta blocker

  5. advanced cup/disc ratios, visual field defects, or scotomas

  6. previous intraocular surgery

  7. proliferative diabetic retinopathy

  8. use of topical steroids


Equivalence of baseline characteristics: yes (preoperative IOP), no (percentage of participants who used beta blockers)
Diagnoses in participants: POAG or ocular hypertension and cataract; participants with pigment dispersion or pseudoexfoliation glaucoma also included
Interventions Intervention 1: combined cataract surgery (phacoemulsification) with IOL implantation and trabecular aspiration (trabeculotomy ab externo)
Intervention 2: cataract surgery (phacoemulsification) with IOL implantation alone
Study follow‐up: 24 months
Outcomes Primary outcomes: mean IOP and mean change in IOP
Secondary outcomes: complications, number of glaucoma medications
Adverse events reported: yes
Intervals at which outcomes assessed: 1 day, and 3, 6, 12, and 24 months after surgery
Notes Type of study: published
Study period: not reported
Funding source: not reported
Disclosures of interest: "None of the authors has a proprietary interest in the development or marketing of this technique or in any of the instruments or drugs described in this paper."
Publication language: English
Subgroup analysis: 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 Allocation concealment not reported
Masking (detection bias) High risk "the physician following the patient was not masked as to whether the patient was in the study or control group"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 4 of 106 (4%) participants excluded from analysis: 2/53 in combined surgery group and 2/53 in cataract surgery alone group
Selective reporting (reporting bias) Low risk Results for outcomes described in Methods section of study publication reported
Other bias Low risk None identified