Exfoliation Glaucoma, Cataract
Conditions
Keywords
SLT, iStent
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).
Interventions
PROCEDUREiStent
2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
PROCEDURESLT-laser
1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
PROCEDURECataract surgery
Conventional cataract surgery
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group I: Change in the number of IOP lowering medications compared to baseline | 12 months | Accountability of IOP lowering medications used by the patient |
| Group II: Change in the IOP compared to baseline | 12 months | IOP measured by Goldmann aplanation tonometry (GAT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group I: Change in the IOP compared to baseline | 12 months | IOP measured by GAT |
| Group II: Change in the number of IOP lowering medications compared to baseline | 12 months | Accountability of IOP lowering medications used by the patient |
Other
| Measure | Time frame | Description |
|---|---|---|
| Group I and II: Number of patients with secondary glaucoma surgery | 10 years | Number of patients with secondary glaucoma surgery at 10 years from baseline is counted |
Countries
Finland
Contacts
Primary ContactEeva Ojanen, MD
Outcome results
None listed