Clinical Research Directory

Trabeculectomy Versus MicroShunt Implantation in Glaucoma Surgery (TIGER)

Sponsor: Oslo University Hospital

Summary

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.

Official title: Trabeculectomy Versus MicroShunt Implantation in Glaucoma Surgery: a Randomized Clinical Trial (TIGER)

Key Details

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Interventions

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