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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure: KDB | Active Comparator | Cataract surgery combined with Kahook Dual Blade goniotomy. |
|
| Procedure: iStent | Active Comparator | Cataract surgery in combination with iStent Inject W implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goniotomy with KDB blade goniotomy | Device | Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of intraocular pressure lowering medications compared to baseline | Accountability of intraocular pressure lowering medications used by the patient | From enrollment to the end of treatment at 12 months |
| Intraocular pressure measured by Goldmann applanation tonometry (GAT) | Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline | From enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg | Intraocular pressure measured by Goldmann applanation tonometry (GAT) at 12 months | From enrollment to the end of treatment at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanna Konopinska | Contact | +48600471666 | joanna.konopinska@umb.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Bialystok | Recruiting | Bialystok | Polska | 15-866 | Poland |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Two iStent inject implanation | Device | The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision. |
|
| Ophthalmology Clinic Medical University of Bialystok | Recruiting | Bialystok | 15-089 | Poland |
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