Rosentreter 2014.
| Methods |
Study design: parallel‐group randomized controlled trial
Number randomized: 30 eyes of 30 participants total; 15 eyes of 15 participants in each group Exclusions after randomization: none reported Losses to follow‐up: 5 participants total; 4 participants in trabeculectomy + Ologen® group; 1 participant in trabeculectomy + MMC group Unit of analysis: individual (1 eye per participant) Number analyzed: 25 participants total; 14 participants in trabeculectomy + Ologen® group; 11 participants in trabeculectomy + MMC group How were missing data handled?: 5 participants excluded from analysis Power calculation: a power of 50% to detect 2.73 mm Hg IOP difference between groups and a power of 95% for a difference of 5.03 mm Hg in IOP |
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| Participants |
Country: Germany
Mean age: 66.4 years; not reported by intervention group
Gender: 13/30 (43%) men and 17/30 (57%) women; not reported by intervention group
Inclusion criteria: “primary or secondary open‐angle glaucoma with uncontrolled IOP while receiving maximal tolerable anti‐glaucomatous therapy"
Exclusion criteria: “angle‐closure glaucoma, posttraumatic, uveitic, neovascular, or dysgenetic glaucoma were not considered for this study. Participants with an allergy to collagen, preliminary conjunctival damage (due to trauma, vitreoretinal surgery, previous glaucoma surgery or other causes) as well as those younger than 18 years of age were excluded from the study.” Equivalence of baseline characteristics: yes |
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| Interventions |
Intervention 1: trabeculectomy + Ologen® (Version 2; Aeon Astron Europe BV, the Netherlands)
Intervention 2: trabeculectomy + MMC Length of follow‐up: Planned: 12 months Actual: 12 months |
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| Outcomes |
Primary outcomes, as defined: IOP, number of glaucoma medications used, bleb morphology Secondary outcomes, as defined: visual acuity, visual field, absolute success ("IOP of 18 mm Hg or lower and an additional reduction of 20% or more in IOP compared to the preoperative IOP, without any additional glaucoma surgery, but with topical medication of a maximum medication score of 2 allowed"), and complications Intervals at which outcomes assessed: 1 day, 7 days, and 1, 3, 6, and 12 months (except visual field at 12 months only) |
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| Notes |
Publication type: published article Funding sources: “PJ Dahlhausen & Co. GmbH (Cologne, Germany) supported the study” Disclosures of interest: "no authors have any financial/conflicting interests to disclose" Trial registry: ClinicalTrials.gov: NCT01174420 Study period: not reported Subgroup analyses: none reported Publication language: English Authors not contacted |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was performed by a person not involved in the study by drawing lots." |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
| Masking of participants and personnel (performance bias) | Low risk | Because trabeculectomy is a surgical procedure with informed consent, masking of the participants and personnel becomes impossible. However, given that a strict and standardized surgical protocol was followed and differences in the surgical protocol of the 2 groups were minimized, the risk of performance bias is comparably low for a surgical procedure |
| Masking of outcome assessment (detection bias) | High risk | It is not possible to mask outcome assessors, as devices can be seen during eye examination |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 25/30 eyes completed 1‐year follow‐up of the study |
| Selective reporting (reporting bias) | Low risk | The study was registered in www.ClinicalTrials.gov. All defined outcomes in www.ClinicalTrials.gov were reported in full text |
| Other bias | Unclear risk | Total industry support but not other source of potential bias identified. |