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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stable glaucoma iStent | Experimental | Cataract surgery combined with iStent inject |
|
| Stable glaucoma SLT-laser | Experimental | Cataract surgery combined with SLT-laser 1 month after surgery |
|
| Stable glaucoma | Active Comparator | Cataract surgery |
|
| Unstable glaucoma iStent | Experimental | Cataract surgery combined with iStent inject |
|
| Unstable glaucoma SLT-laser | Experimental | Cataract surgery combined with SLT-laser 1 month after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent | Procedure | 2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork |
|
| Measure | Description | Time Frame |
|---|---|---|
| Group I: Change in the number of IOP lowering medications compared to baseline | Accountability of IOP lowering medications used by the patient | 12 months |
| Group II: Change in the IOP compared to baseline | IOP measured by Goldmann aplanation tonometry (GAT) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Group I: Change in the IOP compared to baseline | IOP measured by GAT | 12 months |
| Group II: Change in the number of IOP lowering medications compared to baseline | Accountability of IOP lowering medications used by the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Group I and II: Number of patients with secondary glaucoma surgery | Number of patients with secondary glaucoma surgery at 10 years from baseline is counted | 10 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eeva Ojanen, MD | Contact | +358503608589 | eeva.ojanen@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Mika Harju, MD, prof. | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | Finland |
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| ID | Term |
|---|---|
| D017889 | Exfoliation Syndrome |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| SLT-laser | Procedure | 1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees) |
|
|
| Cataract surgery | Procedure | Conventional cataract surgery |
|
| 12 months |