A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Exfoliation Glaucoma
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- Group I: Change in the number of IOP lowering medications compared to baseline
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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).
Investigators
Prof. Mika Harju
MD, professor
Helsinki University Central Hospital
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
Outcomes
Primary Outcomes
Group I: Change in the number of IOP lowering medications compared to baseline
Time Frame: 12 months
Accountability of IOP lowering medications used by the patient
Group II: Change in the IOP compared to baseline
Time Frame: 12 months
IOP measured by Goldmann aplanation tonometry (GAT)
Secondary Outcomes
- Group II: Change in the number of IOP lowering medications compared to baseline(12 months)
- Group I: Change in the IOP compared to baseline(12 months)