Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

Not Applicable

Recruiting

• Conditions: Cataract; Exfoliation Glaucoma

• Registration Number: NCT04635020
• Lead Sponsor: Helsinki University Central Hospital

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).

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-29
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-17
• Last Update Submitted: 2020-11-17
• Study First Posted: 2020-11-18
• Last Update Posted: 2020-11-18
• Primary Completion: 2023-09
• Study Completion: 2033-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 285

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Group II: Change in the IOP compared to baseline	12 months	IOP measured by Goldmann aplanation tonometry (GAT)
Group I: Change in the number of IOP lowering medications compared to baseline	12 months	Accountability of IOP lowering medications used by the patient

Secondary Outcome Measures

Name	Time	Method
Group II: Change in the number of IOP lowering medications compared to baseline	12 months	Accountability of IOP lowering medications used by the patient
Group I: Change in the IOP compared to baseline	12 months	IOP measured by GAT

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland