Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma

Xerencia de Xestión Integrada de Ferrol350 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Pseudoexfoliation Syndrome Pseudoexfoliation Glaucoma in Both Eyes Open Angle Glaucoma

Interventions

Xen Gel Stent implantationDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

INTRAOCULAR PRESSURE

The primary outcome measure will be intraocular pressure reduction at final follow up

Time frame: 12-48 months

Secondary Outcomes

NUMBER OF TREATMENTS

Number of glaucoma drugs: Investigate the reduction of drugs after surgery

Time frame: 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

Time frame: 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)

Time frame: 12-48 months

RATES OF REINTERVENTION

Number of trabeculectomy or filtering surgery required as a result of poor control of IOP

Time frame: 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.

Time frame: 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.

Time frame: 12-48 months

Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes