iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma
| Registry | NCT07325552, acronym iSKDB |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Medical University of Bialystok (Other) |
| Conditions | Open Angle Glaucoma (OAG) |
| Interventions | Goniotomy with KDB blade goniotomy, Two iStent inject implanation (Device) |
| Dates | start 2026-01-01, primary completion 2027-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-01-08, last updated 2026-01-08 |
| Locations | 2 sites in Poland |
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All trials for Open Angle Glaucoma (OAG) All trials of Goniotomy with KDB blade goniotomy All trials of Two iStent inject implanation
The purpose of the study is to investigate the efficacy of cataract surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.
Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery combined with Kahook Dual Blade Glide (50 patients) or iStent Inject W (50 patients).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Procedure: KDB | Active comparator | Device: Goniotomy with KDB blade goniotomy | Cataract surgery combined with Kahook Dual Blade goniotomy. |
| Procedure: iStent | Active comparator | Device: Two iStent inject implanation | Cataract surgery in combination with iStent Inject W implantation |
Sex: All, ages: 18 Weeks to any
Inclusion Criteria: * Only one eye per participant * Clinically significant cataract * Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment. * Open chamber angle with Schaffer grading three to four in at least two quadrants Exclusion Criteria: * Previous glaucoma surgery, including cyclodestructive procedures. * Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery. * Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field. * Unable to participate and make written consent due to another medical condition.
| Facility | City | Country | Status |
|---|---|---|---|
| Medical University of Bialystok | Bialystok, Polska | Poland | Recruiting |
| Ophthalmology Clinic Medical University of Bialystok | Bialystok | Poland | Recruiting |