Trabeculectomy Versus MicroShunt Implantation in Glaucoma Surgery (TIGER)

ConditionGlaucoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorOslo University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Preserflo MicroShunt

    Procedure/Surgery

    Filtering surgery with implantation of shunt made by SIBS material

  • Trabeculectomy

    Procedure/Surgery

    Filtering surgery with creation of canal with surgical instruments and sutures

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: TrabeculectomyActive comparator 1 intervention
Group B: Preserflo MicroShuntActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraocular pressure measured with Goldmann Applanation Tonometry

Time frame
From enrollment to the end of follow-up at 5 years.
2

Number of glaucoma medications

Time frame
From enrollment to the end of follow-up at 5 years.
3

Corrected distance visual acuity (CDVA)

Time frame
At enrollment, 3 months, one year, two years and 5 years after the two treatments.
4

Progression of the visual field (in particular change in MD)

Time frame
From enrollment to the end of follow-up at 5 years.

Secondary outcomes

1

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.
2

Macular thickness measured with OCT

Time frame
From enrollment to the end of follow-up at 5 years.
3

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.
4

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.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: