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Combined and stand‐alone XEN 45 gel stent implantation: 3‐year outcomes and success predictors
- Source :
- Acta Ophthalmologica (2020)
- Publication Year :
- 2020
- Publisher :
- Wiley, 2020.
-
Abstract
- Purpose: To evaluate the 3-year treatment outcomes of XEN 45 gel stent in open-angle glaucoma patients. Methods: In this prospective, single-centre interventional study, consecutive eyes with uncontrolled intraocular pressure (IOP) or signs of disease progression despite medical treatment underwent XEN implantation either alone or combined with phacoemulsification (Phaco + XEN). Main outcome measures: Surgical success was defined as 'complete' when 36-month unmedicated IOP was ≤15 mmHg with a relative IOP reduction ≥ 20% from medicated baseline, while the definition of qualified success allowed no more medications than at baseline. Other definitions of success with different IOP thresholds were also analysed. Secondary outcomes included mean IOP reduction, changes in ocular hypotensive medications and rates of reoperations. Results: Out of 149 eyes initially included, 92 eyes (61.7%) of 68 patients had complete 3-year data (XEN: n = 26; Phaco + XEN: n = 66) after 38.2% were lost to follow-up. Mean age was 76.3 ± 9.1 years, and 66.2% were female. Mean medicated IOP decreased from 20.8 ± 7.4 mmHg (21.0 ± 7.4 [XEN] vs. 20.0 ± 6.9 mmHg [Phaco + XEN]) at baseline to 13.1 ± 3.4 mmHg (12.9 ± 2.9 [XEN] vs. 12.9 ± 3.4 [Phaco + XEN]) at 3 years (-37.0%; p < 0.001). Medications decreased from 1.9 ± 1.3 (2.4 ± 1.5 [XEN] vs. 1.9 ± 1.2 [Phaco + XEN]) to 0.4 ± 0.9 (0.3 ± 0.8 [XEN] vs. 0.5 ± 0.9 [Phaco + XEN]) (-78.9%; p < 0.001). Complete success and qualified success were achieved in 29.0% and 31.0% of eyes, respectively. Needling revision was performed in 51 eyes (55.4%), and 26.1% underwent reoperations. Risk factors for surgical failure included male gender (odds ratio [OR]:3.6; p = 0.03), diagnosis of POAG (OR: 4.5; p < 0.01) and undergoing needling revision (OR: 4.6; p < 0.01). While the type of procedure had no effect on the outcomes of PEXG, POAG eyes undergoing combined surgery had significantly higher rates of failure (OR: 7.29; p = 0.023). Most patients stable at 12-month remained so through to 3 years. Conclusions: At 3 years, XEN gel stent implantation achieved clinically significant IOP and medication reduction despite relatively high rates of needling and reoperations. Identifying patients at risk preoperatively may help optimize surgical outcomes.
- Subjects :
- Male
medicine.medical_specialty
Intraocular pressure
Time Factors
genetic structures
Minimally invasive glaucoma surgery
medicine.medical_treatment
Glaucoma
Prosthesis Design
Surgery
Prosthesis Implantation
03 medical and health sciences
0302 clinical medicine
Open-angle
medicine
Humans
Stent implantation
POAG
PEXG
Prospective Studies
Glaucoma Drainage Implants
Intraocular Pressure
Aged
Dry needling
business.industry
MIGS
Stent
General Medicine
Phacoemulsification
Odds ratio
medicine.disease
eye diseases
Prospective
Ophthalmology
Pseudoexfoliative
Treatment Outcome
030221 ophthalmology & optometry
Female
Stents
business
Gels
Glaucoma, Open-Angle
030217 neurology & neurosurgery
Follow-Up Studies
Subjects
Details
- ISSN :
- 17553768 and 1755375X
- Volume :
- 99
- Database :
- OpenAIRE
- Journal :
- Acta Ophthalmologica
- Accession number :
- edsair.doi.dedup.....473b2f53473e29498fcb0059c547e21d