Clinical trial NCT04635020: Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group
Official title: A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exfoliation Glaucoma
Cataract
Keywords: SLT
iStent
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 285
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF)

Detailed description: Exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. Patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with iStent (65 patients), II SLT (65 patients) or III cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with I iStent (65 patients), II SLT (65 patients).

Eligibility criteria: Inclusion Criteria:

* Signed consent of information
* Clinical significant cataract
* Able to attend 12 month period
* Mild to moderate exfoliation glaucoma according to European glaucoma society guidelines (EGS)
* Group I stable glaucoma (IOP within individual target IOP), and group II unstable glaucoma (IOP above individual target IOP) with baseline glaucoma medication
* Target IOP ≥16
* Able to understand Finnish, Swedish or English

Exclusion Criteria:

* Clinical set target IOP \< 16 mmHg in advanced glaucoma
* Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications
* Closed angle
* Congenital angle anomaly
* Clinically significant corneal dystrophy or other hindering corneal condition
* Unable to use topical medical therapy
* Central corneal thickness of less than 480um or more than 620um
* Active uveitis, cystic macular edema (CME), exudative age-related macular degeneration, proliferative diabetic retinopathy or clinical significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, phacodonesis.
* Previous intraocular surgery, refractive surgery or cycloablation
* Two or more prior SLT or laser trabeculoplasty
* Unable to participate due to another medical disease or condition
* Participating in another clinical trial

Primary outcomes:
measure: Group I: Change in the number of IOP lowering medications compared to baseline
timeFrame: 12 months
measure: Group II: Change in the IOP compared to baseline
timeFrame: 12 months
Secondary outcomes:
measure: Group I: Change in the IOP compared to baseline
timeFrame: 12 months
measure: Group II: Change in the number of IOP lowering medications compared to baseline
timeFrame: 12 months
Other outcomes:
measure: Group I and II: Number of patients with secondary glaucoma surgery
timeFrame: 10 years
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Mika Harju, MD, prof.
role: PRINCIPAL_INVESTIGATOR
References: