About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary filtering surgery in the given eye
Ability to cooperate fairly well
Willingness to participate
Disqualifiers
Low target IOP
Previous filtering surgery in the same eye
Corneal decompensation
Juvenile glaucoma
Trial design
Parallel
Treatments tested in this trial
Preserflo MicroShunt
Procedure/SurgeryFiltering surgery with implantation of shunt made by SIBS material
Trabeculectomy
Procedure/SurgeryFiltering surgery with creation of canal with surgical instruments and sutures
Treatment groups
Trial outcomes
Primary outcomes
Intraocular pressure measured with Goldmann Applanation Tonometry
Number of glaucoma medications
Corrected distance visual acuity (CDVA)
Progression of the visual field (in particular change in MD)
Secondary outcomes
Flare in the anterior chamber measured with a laserflare meter in photoncounts per millisecond (pc/ms)
Macular thickness measured with OCT
Retinal nerve fibre layer (RNFL) measured in micrometers with OCT
Optic disc imaging using using Nidek RS -3000 Advance II OCT
EQ-5D and NEI-VFQ 25 questionnaires for self-reported health and life quality
Sponsors and contacts
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