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| Name | Class |
|---|---|
| Medical University of Lublin | OTHER |
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Study aims to compare the effectiveness and safety profile of Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Gonioscopy-assisted Transluminal Trabeculotomy is the procedure that aims the same mechanism of aqueous outflow, however is perform with ab interno approach, which comprise it to the minimally invasive glaucoma surgery techniques. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication burden and complications rate. So far there is no comparison of the Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canaloplasty | Active Comparator | Canaloplasty ab externo |
|
| Gonioscopy-assisted Transluminal Trabeculotomy | Active Comparator | Gonioscopy-assisted Transluminal Trabeculotomy ab interno |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| canaloplasty | Procedure | canaloplasty ab interno with tensioning suture |
|
| Measure | Description | Time Frame |
|---|---|---|
| success rate (complete and qualified success) | Success is defined: 1. IOP < 21 mmHg and at least 20% IOP change from baseline 2. IOP < 18 mmHg | 12 months |
| success rate (complete and qualified success) | Success is defined: 1. IOP < 21 mmHg and at least 20% IOP change from baseline 2. IOP < 18 mmHg | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| IOP, medication, complications | intraocular pressure change, medication postoperatively, complications intra- and postoperatively | 12 months |
| IOP, medication, complications | intraocular pressure change, medication postoperatively, complications intra- and postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanna Konopińska | Contact | +48600471666 | joannakonopinska@o2.pl | |
| Ewa Kosior-Jarecka | Contact | ekosior@poczta.onet.pl |
| Name | Affiliation | Role |
|---|---|---|
| Joanna Konopińska | Medical University of Bialystok, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Clinic Medical University of Bialystok | Recruiting | Bialystok | 15-089 | Poland |
All materials and information are available upon an e-mail request on principal investigator
5 years
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Gonioscopy-assisted Transluminal Trabeculotomy | Procedure | Gonioscopy-assisted Transluminal Trabeculotomy ab interno |
|
| 24 months |