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

Jacobi 1999.

Methods Study design: parallel‐group RCT
Unit of randomization: the individual (one eye per participant)
Number randomized: 48 total; 26 eyes of 26 participants in combined surgery group and 22 eyes of 22 participants in cataract surgery alone group
Unit of analysis: the individual (one eye per participant)
Number analyzed: 20 total; 13 eyes of 13 participants in combined surgery group and 7 eyes of 7 participants in cataract surgery alone group at 30 months
Exclusions and losses to follow‐up:
At one year: none in combined surgery group and 6 eyes of 6 participants in cataract surgery alone group
At 30 months: 13 eyes of 13 participants in combined surgery group and 15 eyes of 15 participants in cataract surgery alone group
Power calculation: none reported
Participants Country: Cologne, Germany (one site)
Age (mean ± SD): 69.4 ± 5.6 years (range: 52 to 77) in combined surgery group; 71.3 ± 6.1 years (range: 48 to 78) in cataract surgery alone group
Gender: 10 men and 16 women in combined surgery group; 10 men and 12 women in cataract surgery alone group
Ethnicity: not reported
Inclusion criteria:

  1. coexisting cataract and PEXG requiring glaucoma medical therapy

  2. at risk IOP spike‐related optic nerve head damage during postoperative period

  3. long‐term glaucoma control in terms of IOP or medical dependency

  4. improvement for lens‐related visual acuity


Exclusion criteria:

  1. glaucoma other than PEXG

  2. narrow angle

  3. previous filtering or cyclodestructive procedures

  4. history of uveitis, herpetic keratitis, or ocular trauma


Equivalence of baseline characteristics: yes (age, sex, severity of glaucoma (vertical cup‐to‐disc ratio), number of glaucoma medications, IOP, visual severity of cataract, presence of diabetes, hypertension, or age‐related maculopathy)
Diagnoses in participants: PEXG and cataract
Interventions Intervention 1: combined cataract surgery (phacoemulsification) with IOL implantation and trabecular aspiration
Intervention 2: cataract surgery (phacoemulsification) with IOL implantation alone
(Intervention 3: triple procedure (standard trabeculectomy, phacoemulsification, and IOL implantation); this group excluded from this report because it consisted of patients who opted out of the trial and therefore were not randomized)
Study follow‐up: 30 months
Outcomes Primary outcome: mean change in IOP
Secondary outcomes:

  1. mean number of glaucoma medications

  2. BCVA

  3. complications


Adverse events reported: yes
Intervals at which outcomes assessed: 1 and 2 weeks, and 1, 3, 6, 12, 24, and 30 months after surgery
Notes Type of study: published
Study period: not reported
Funding source: Deutsche Forschungsgemeinschaft, Bonn, Germany
Disclosures of interest: "None of the authors has any proprietary interest in the development or marketing of equipment used in this study or any competing piece of equipment."
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) Low risk "Goldmann applanation tonometry was done at the slitlamp in a double‐masked fashion by the same examiner"
Incomplete outcome data (attrition bias) 
 All outcomes High risk 28 of 48 (53%) participants excluded from 30 months analysis: 13/26 in combined surgery group and 15/22 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