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| Name | Class |
|---|---|
| University Hospital Complex of Santiago de Compostela | UNKNOWN |
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The Xen implant is an ab interno device that has been shown to be effective in reducing intraocular pressure in several types of glaucoma, although the evidence in pseudoexfoliative glaucoma is limited. The present retrospective observational study aims to increase knowledge about the long-term effectiveness and safety of the implant in pseudoexfoliative glaucoma. Researchers will compare the results with data from patients with open-angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pseudoexfoliation glaucoma |
| ||
| Open-angle glaucoma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xen Gel Stent implantation | Device | Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| INTRAOCULAR PRESSURE | The primary outcome measure will be intraocular pressure reduction at final follow up | 12-48 months |
| Measure | Description | Time Frame |
|---|---|---|
| NUMBER OF TREATMENTS | Number of glaucoma drugs: Investigate the reduction of drugs after surgery | 12-48 months |
| BEST CORRECTED VISUAL ACUITY | Best-corrected visual acuity (BCVA): investigators will compare the change of visual acuities (VA) between pre-surgery to last follow-up |
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Inclusion Criteria:
Data will be collected for all patients with pseudoexfoliation glaucoma (PXFG), ocular hypertension (OHT) and pseudoexfoliation syndrome, POAG and other secondary open angle glaucoma (OAG) diagnosed, who underwent surgery from 2018 to 2022.
Patients should be candidates for filtering glaucoma surgery for the following indications:
Refractory glaucoma and eyes with previous filtering surgery, previous laser treatments or micropulse transscleral cyclophotocoagulation will be also included.
Exclusion Criteria:
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Data will be collected for all patients with PXFG, POAG and other secondary OAG, who underwent surgery from 2018 to 2022, at 2 terciary care academic ophthalmology centers (University Hospital Complex of Ferrol and University Hospital Complex of Santiago de Compostela, Spain) by 10 surgeons.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sara Pose-Bazarra | Ferrol | Spain |
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| ID | Term |
|---|---|
| D017889 | Exfoliation Syndrome |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| 12-48 months |
| RETINAL NERVE FIBER LAYER | Retinal nerve fiber layer (RNFL) thickness by optical coherence tomography (OCT): investigators will compare the reduction in the retinal nerve fiber layer by OCT according to the analysis of glaucoma (Heidelberg) | 12-48 months |
| RATES OF REINTERVENTION | Number of trabeculectomy or filtering surgery required as a result of poor control of IOP | 12-48 months |
| INCIDENCE OF TREATMENT ADVERSE EVENTS | Investigators will determine the safety profile of the intervention through an evaluation of intraoperative and post-operative complications. All adverse events or complications related to the intervention will be recorded in a descriptive manner. | 12-48 months |
| PRESERVATIVES EXPOSURE | Investigators will collect data on pre-surgery treatment regarding the use or non-use of preservatives and their exposure time to these drugs to compare effectiveness outcomes in both groups. | 12-48 months |
| D009798 |
| Ocular Hypertension |