Open Angle Glaucoma, Pseudoexfoliation Glaucoma in Both Eyes, Pseudoexfoliation Syndrome
Conditions
Keywords
Xen
Brief summary
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.
Interventions
DEVICEXen Gel Stent implantation
Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022
Sponsors
University Hospital Complex of Santiago de Compostela
Xerencia de Xestión Integrada de Ferrol
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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: * uncontrolled intraocular pressure (IOP) * intolerance or non-adherence to topical treatment * glaucoma progression despite topical therapy * surgical cataract patients undergoing phacoemulsification, who were treated with two or more hypotensive drugs and wished to withdraw the medication due to side effects and/or discomfort of the treatment. Refractory glaucoma and eyes with previous filtering surgery, previous laser treatments or micropulse transscleral cyclophotocoagulation will be also included.
Exclusion criteria
* Patients with follow up less than 12 months. * Patients with end-stage glaucoma, uveitic and angle closure glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| INTRAOCULAR PRESSURE | 12-48 months | The primary outcome measure will be intraocular pressure reduction at final follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BEST CORRECTED VISUAL ACUITY | 12-48 months | Best-corrected visual acuity (BCVA): investigators will compare the change of visual acuities (VA) between pre-surgery to last follow-up |
| RETINAL NERVE FIBER LAYER | 12-48 months | 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) |
| NUMBER OF TREATMENTS | 12-48 months | Number of glaucoma drugs: Investigate the reduction of drugs after surgery |
| INCIDENCE OF TREATMENT ADVERSE EVENTS | 12-48 months | 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. |
| PRESERVATIVES EXPOSURE | 12-48 months | 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. |
| RATES OF REINTERVENTION | 12-48 months | Number of trabeculectomy or filtering surgery required as a result of poor control of IOP |
Countries
Spain
Outcome results
None listed