An interventional study of Preserflo MicroShunt and Trabeculectomy in Glaucoma, sponsored by Oslo University Hospital. Not yet recruiting at 1 site in Norway. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
Glaucoma is an eye disease causing vision loss if not treated adequately. The prevalence is around 1.5%, exponentially increasing to more than 10% in the elderly. Trabeculectomy has been the gold standard surgery for decades and is an evidence based choice for glaucoma surgery. In the last years, new operation methods with shunts or stents (MIGS) have been introduced, however, the scientific evidence for the efficacy and safety of these new methods are scarce and the cost is considerable. Nevertheless, the use has increased, likely due to a shorter learning curve for surgery. The aim of the present project is to perform a randomized clinical trial comparing trabeculectomy versus Preserflo MicroShunt surgery in patients with glaucoma, and to compare the efficacy (intraocular pressure reduction), the safety (in terms of complication rate) and cost-efficiency. The project targets a large patient group and a considerable resource use in Norwegian opthalmology departments.
Main aim: to optimize treatment in glaucoma patients by evaluating surgical treatment strategies and guidelines. Objectives: to compare trabeculectomy (gold standard) versus Preserflo microshunt implantation (less invasive surgery) in glaucoma patients in a randomized trial comparing several parameters such as intraocular pressure, number of glaucoma medications, vision and the safety (including complications, corneal endothalial cell loss and need for re-operations) between these two groups.
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 1,296 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.
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Exclusion Criteria:
Procedure: Trabeculectomy
Procedure: Preserflo MicroShunt
Filtering surgery with implantation of shunt made by SIBS material
Filtering surgery with creation of canal with surgical instruments and sutures
Intraocular pressure measured with Goldmann Applanation Tonometry
Time frame: From enrollment to the end of follow-up at 5 years.
Number of glaucoma medications
Time frame: From enrollment to the end of follow-up at 5 years.
Corrected distance visual acuity (CDVA)
Time frame: At enrollment, 3 months, one year, two years and 5 years after the two treatments.
Progression of the visual field (in particular change in MD)
Time frame: From enrollment to the end of follow-up at 5 years.
Endothelial cell density (ECD)
Time frame: From enrollment to the end of follow-up at 5 years.
Flare in the anterior chamber measured with a laserflare meter in photoncounts per millisecond (pc/ms)
Time frame: From enrollment to the end of follow-up at 5 years.
Macular thickness measured with OCT
Time frame: From enrollment to the end of follow-up at 5 years.
Retinal nerve fibre layer (RNFL) measured in micrometers with OCT
Optic disc imaging using using Nidek RS -3000 Advance II OCT
Time frame: From enrollment to the end of follow-up at 5 years.
EQ-5D and NEI-VFQ 25 questionnaires for self-reported health and life quality
Time frame: From enrollment to the end of follow-up at 5 years.
Cost-effectiveness analysis (CEA) of the two intervention groups
We will register guiding prices for the two treatments - related to the intervention, cost of equipment and possible additional treatments/re-operations in the postoperative period (e.g. complications) and the number of additional postoperative controls.
Time frame: From enrollment to the end of follow-up at 5 years.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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