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| ID | Type | Description | Link |
|---|---|---|---|
| TVC | Other Identifier | University Eye Hospital Wurzburg |
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Study aims for comparison of trabeculectomy 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. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabeculectomy | Active Comparator | Trabeculectomy with Mitomycin C |
|
| Canaloplasty | Active Comparator | Canaloplasty with implant of suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trabeculectomy | Procedure | trabeculectomy with mitomycin C 0.2mg/ml |
| |
| Measure | Description | Time Frame |
|---|---|---|
| success rate (complete and qualified success) | Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg | 1 year |
| success rate (complete and qualified success) | Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| IOP, medication, complications | intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively | 1 year |
| IOP, medication, complications | intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively |
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Inclusion Criteria:1. diagnosed primary or secondary open-angle glaucoma 2. IOP > 16 mmHg (<60 days prior surgery) 3. IOP > 21 mmHg 4. no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Klink, MD | University Eye Hospital, Würzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Eye Hospital | Würzburg | Bavaria | 97080 | Germany |
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| ID | Term |
|---|---|
| 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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| Canaloplasty |
| Procedure |
Canaloplasty with implant of suture |
|
| 2 years |