GlaucomaNCT07869108
Trabeculectomy Versus MicroShunt Implantation in Glaucoma Surgery (TIGER)
A study testing Preserflo MicroShunt and Trabeculectomy in people with Glaucoma, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Preserflo MicroShunt and Trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2026to 31 Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary filtering surgery in the given eye
- Ability to cooperate fairly well
- Willingness to participate
Who cannot join
- Low target IOP
- Previous filtering surgery in the same eye
- Corneal decompensation
- Juvenile glaucoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Department of Ophthalmology, University of Oslo
Oslo, Oslo
Olav Kristianslund, MD, PhD, +4722118545, olakri@ous-hf.no
About this study
Official title: Trabeculectomy Versus MicroShunt Implantation in Glaucoma Surgery: a Randomized Clinical Trial (TIGER)
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.
- Conditions
- Glaucoma
- Being tested
- Preserflo MicroShunt, Trabeculectomy
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserflo MicroShuntProcedure or surgery
Filtering surgery with implantation of shunt made by SIBS material
TrabeculectomyProcedure or surgery
Filtering surgery with creation of canal with surgical instruments and sutures
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy | Active comparator | Not described Receives: Procedure: Trabeculectomy |
| Preserflo MicroShunt | Active comparator | Not described Receives: Procedure: Preserflo MicroShunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure measured with Goldmann Applanation Tonometry
Measured: From enrollment to the end of follow-up at 5 years.
Number of glaucoma medications
Measured: From enrollment to the end of follow-up at 5 years.
Corrected distance visual acuity (CDVA)
Measured: 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)
Measured: From enrollment to the end of follow-up at 5 years.
Endothelial cell density (ECD)
Measured: From enrollment to the end of follow-up at 5 years.
Secondary outcomes (5)
Flare in the anterior chamber measured with a laserflare meter in photoncounts per millisecond (pc/ms)
Measured: From enrollment to the end of follow-up at 5 years.
Macular thickness measured with OCT
Measured: 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
Measured: 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
Measured: 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.
Measured: From enrollment to the end of follow-up at 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olav Kristianslund, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869108
- Sponsor's protocol ID
- 813796
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trabeculectomy Versus MicroShunt Implantation in Glaucoma Surgery: a Randomized Clinical Trial (TIGER)
- ClinicalTrials.gov ID
- NCT07869108
- Acronym / sponsor ID
- 813796
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy | Active comparator | Procedure: Trabeculectomy |
| Preserflo MicroShunt | Active comparator | Procedure: Preserflo MicroShunt |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary filtering surgery in the given eye
- Ability to cooperate fairly well
- Willingness to participate
Key exclusion criteria (4 listed)
- Low target IOP
- Previous filtering surgery in the same eye
- Corneal decompensation
- Juvenile glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preserflo MicroShuntFiltering surgery with implantation of shunt made by SIBS material | Procedure or surgery | Preserflo MicroShunt |
| TrabeculectomyFiltering surgery with creation of canal with surgical instruments and sutures | Procedure or surgery | Trabeculectomy |
Primary outcome
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.
5 secondary outcomes
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
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
Time frame: From enrollment to the end of follow-up at 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preserflo MicroShunt and Trabeculectomy in people with Glaucoma, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olav Kristianslund, MD, PhD (+4722118545, olakri@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure measured with Goldmann Applanation Tonometry (time frame: From enrollment to the end of follow-up at 5 years.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.