Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group
A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma
Helsinki University Central Hospital
285 participants
Oct 1, 2020
INTERVENTIONAL
Conditions
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)
Eligibility
Inclusion Criteria7
- 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 Criteria12
- 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
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Interventions
2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
Conventional cataract surgery
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04635020