Glaucoma
Conditions
Keywords
glaucoma, surgery, XEN63
Brief summary
The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation.
Detailed description
The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation. Every patients will be followed for 24 months. Secondary aims of the study are: * Evaluating the hypotensive efficacy of the XEN63 12 months after implantation. * Assessing the safety of the XEN63 device after 12 and 24 months after implantation. * Comparing the hypotensive efficacy of the XEN63 in glaucomatous patients undergoing the solo procedure and in those undergoing the combo procedure * Evaluating the quality of life of patients undergoing XEN63 implantation 12 and 24 months after implantation. * Evaluating the association between factors related to the patient, the surgical technique or post-operative management and the hypotensive efficacy of the device during follow-up.
Interventions
None listed
Sponsors
Mario Stirpe
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines. 3. Need for XEN63 implantation for IOP not controlled by medical therapy, progression of disease or intolerance to topical therapy, in association or not with cataract surgery. 4. Informed consent freely given and obtained before the start of the study. 5. The participant has the ability to understand and the willingness to follow the study instructions and is likely to complete all required visits and procedures.
Exclusion criteria
1. Closed-angle glaucoma 2. Previous trabeculectomy or valve or tube placement. 3. Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathologies (e.g. pterygium) in the target quadrant. 4. Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis) 5. Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery 6. Anterior chamber lenses 7. Presence of intraocular silicone oil 8. Vitreous in anterior chamber 9. Altered episcleral venous drainage (e.g. Sturge Webwer syndrome, nanophthalmos) 10. Known or suspected allergy or sensitization to medications required for the surgical procedure or some component of the device (e.g. glutaraldehyde or porcine derivatives) 11. History of predisposition to the formation of keloids. 12. Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP | up to 2 years | IOP values before and after 24 months of XEN63 implant. |
| Number of hypotensive eye drops | up to 2 years | Number of hypotensive eye drops |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP | From enrollment to 12 months after surgery | IOP values before and after 12 months of XEN63 implant. |
| Number of hypotensive eye drops | From enrollment to 12 months after surgery | Number of hypotensive eye drops before and after 12 months of XEN63 implant |
| Complications | up to 2 years | \- Type and number of intraoperative and postoperative complications. |
| Quality of life after XEN63 implant | up to 2 years | Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25) scores over time. The minimum value is 0, the maximum value is 100. Higher score means a better outcome. |
| Surgical tecnique | during the intervention/procedure/surgery | Data on surgical technique: site of XEN63 implant |
| Post operative management | up to 2 years | Post operative treatment: type of steroids used |
| Post operative needling | up to 2 years | Number of needling |
| Surgical revision | up to 2 years | Number of surgical revision |
| Glaucoma Symptom Scale | up to 2 years | A brief symptom survey specific for persons with glaucoma. This score is transformed to a 0 to 100 scale, with 0 representing presence of a very bothersome problem and 100 representing absence of a problem. |
| Surgical technique | during the intervention/procedure/surgery | Data on surgical technique: type of viscoelastic used |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORFrancesco Oddone, MD, PhD
IRCCS-Fondazione GB Bietti
Outcome results
None listed