Trabeculectomy Versus MicroShunt Implantation in Glaucoma Surgery (TIGER)

NCT07869108 | Not Yet Recruiting

• 1 other identifier: 813796
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (5)

• Intraocular pressure measured with Goldmann Applanation Tonometry

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

• Number of glaucoma medications

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

• Corrected distance visual acuity (CDVA)

  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)

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

• Endothelial cell density (ECD)

  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)

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

• Macular thickness measured with OCT

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

• Retinal nerve fibre layer (RNFL) measured in micrometers with OCT

  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

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

• Cost-effectiveness analysis (CEA) of the two intervention groups

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

Study Arms (2)

Trabeculectomy

ACTIVE COMPARATOR

Procedure: Trabeculectomy

Preserflo MicroShunt

ACTIVE COMPARATOR

Procedure: Preserflo MicroShunt

Interventions

Preserflo MicroShunt PROCEDURE

Filtering surgery with implantation of shunt made by SIBS material

Preserflo MicroShunt

Trabeculectomy PROCEDURE

Filtering surgery with creation of canal with surgical instruments and sutures

Trabeculectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary filtering surgery in the given eye
• Ability to cooperate fairly well
• Willingness to participate

You may not qualify if:

• Low target IOP
• Previous filtering surgery in the same eye
• Corneal decompensation
• Juvenile glaucoma

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Ophthalmology, University of Oslo

Oslo, Oslo, Norway

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Olav Kristianslund, MD, PhD

CONTACT

+4722118545; olakri@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Section MD MPh PhD, Clinical Professor, Head of Research Group, Principal Investigator

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2032
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

NO (1)