Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group (COILEH)

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Cataract; Exfoliation Glaucoma

Treatments: Procedure: Cataract surgery; Procedure: SLT-laser; Procedure: iStent

Study type: Interventional

Funder types: Other

Identifiers

NCT04635020

123123

Details and patient eligibility

About

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)

Full 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).

Enrollment: 285 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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285 participants in 5 patient groups

Stable glaucoma iStent

Experimental group

Description:

Cataract surgery combined with iStent inject

Treatment:

Procedure: iStent

Procedure: Cataract surgery

Stable glaucoma SLT-laser

Experimental group

Description:

Cataract surgery combined with SLT-laser 1 month after surgery

Treatment:

Procedure: SLT-laser

Procedure: Cataract surgery

Stable glaucoma

Active Comparator group

Description:

Cataract surgery

Treatment:

Procedure: Cataract surgery

Unstable glaucoma iStent

Experimental group

Description:

Cataract surgery combined with iStent inject

Treatment:

Procedure: iStent

Procedure: Cataract surgery

Unstable glaucoma SLT-laser

Experimental group

Description:

Cataract surgery combined with SLT-laser 1 month after surgery

Treatment:

Procedure: SLT-laser

Procedure: Cataract surgery