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| Name | Class |
|---|---|
| Wrocław University of Science and Technology | OTHER |
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To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stand-alone procedure of XEN implantation in phakic eyes | Active Comparator |
| |
| stand-alone procedure of XEN implantation in pseudophakic eyes | Active Comparator |
| |
| XEN implantation combined with cataract extraction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-fluorouracil | Drug | 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unqualified success | Unqualified success of glaucoma treatment, defined as a postoperative IOP <18 mmHg and >20% reduction compared with the baseline value, achieved without use of any antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Qualified success score A | Qualified success of glaucoma treatment, defined as a postoperative IOP <21 mmHg and >20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Glaucoma Progression | Glaucoma progression was evaluated with the Hodapp-Parrish-Anderson Glaucoma Grading Scale (GGS). Staging according to the standards given in bibliography (Budenz et all in 2002) | 5 years |
| Change in thickness of the retinal nerve fiber layer (RNFL) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Misiuk-Hojło, Professor | Medical University of Wrocław | Study Chair |
| Ewa Wałek | Medical University of Wrocław | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology | Wroclaw | 54-622 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12215086 | Background | Budenz DL, Rhee P, Feuer WJ, McSoley J, Johnson CA, Anderson DR. Comparison of glaucomatous visual field defects using standard full threshold and Swedish interactive threshold algorithms. Arch Ophthalmol. 2002 Sep;120(9):1136-41. doi: 10.1001/archopht.120.9.1136. | |
| 19834563 | Background | Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Transconjunctival needling | Procedure | Transconjunctival needling was administered according to predetermined criteria. |
|
| Transconjunctival revision | Procedure | Transconjunctival revision was administered according to predetermined criteria. |
|
| Qualified success score B |
Qualified success of glaucoma treatment, defined as a postoperative IOP < 18 mmHg and >20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit. |
| 5 years |
| Qualified success score C | Qualified success of glaucoma treatment, defined as a postoperative IOP ≤15 mmHg and >40% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit. | 5 years |
Difference in thickness of the retinal nerve fiber layer during the observation time frame. |
| 5 years |
| Change in thickness of ganglion cell complex (GCC) | Difference in thickness of ganglion cell complex during the observation time frame. | 5 years |
| Short term changes in IOP after surgery | Evaluated with the use of water drinking test. | 5 years |
| Refractive error | Change in refractive error after glaucoma procedures | 5 years |
| Best-corrected visual acuity | Evaluated on the fixed charts by trained optometrist | 5 years |
| Visual field (VF) | Detection of the visual field abnormalities on the standard machine and during screening procedures | 5 years |
| Disc damage likelihood scale (DDLS) | Evaluation disc damage likelihood scale based on the fundus photographs | 5 years |
| Peripapillar and macular vessels density | Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA) | 5 years |
| D006571 |
| Heterocyclic Compounds |