None listed
Conditions
Brief summary
This is a multi-center, prospective, open-label, post-market registry of the safety and efficacy following implantation of iStent inject W stents (G2W), with or without phacoemulsification, in eyes with OAG in a real-world clinical setting. All patients will be evaluated at a preoperative visit the post-operative visita on Day 1, Week 1, and Month 1, 3, 6, 12, 18 and 24 after treatment. Slit lamp and fundus/optic nerve assessments, Gonioscopy, Pachymetry, Visual Field (VF) and Optical Coherence Tomography (OCT) assessment f Retinal nerve fiber layer (RNFL) will be performed at pretreatment baseline and at appropriate times after treatment. it is expected the intervention will demonstrate clinically significant IOP-lowering with a good safety profile.
Interventions
Insertion of 3 trabecular bypass stents (iStent inject W) with or without cataract surgery.
1. Receipt of treatment is not conditional on participation in the study (patients meeting inclusion/exclusion criteria not wishing to be enrolled in a study are still eligible to receive the described treatment)
2. Follow-up from the date of treatment will be a minimum 24 months with assessments at 3-6 monthly intervals after the initial post-operative phase.
3. Follow-up will require a 1 hour appointme
Insertion of 3 trabecular bypass stents (iStent inject W) with or without cataract surgery. 1. Receipt of treatment is not conditional on participation in the study (patients meeting inclusion/exclusion criteria not wishing to be enrolled in a study are still eligible to receive the described treatment) 2. Follow-up from the date of treatment will be a minimum 24 months with assessments at 3-6 monthly intervals after the initial post-operative phase. 3. Follow-up will require a 1 hour appointment during which primary and secondary outcome measures will be assessed 4. The istent inject W (x3) will be injected into the nasal trabecular meshwork, @ 2 clock-hour intervals, at the time of cataract surgery or as a stand-alone procedure under topical or local anaesthesia in an operating theatre 5. Stents will be inserted by an ophthalmologist experienced in the use of the istent inject device. 6. Confirmation of iStent inject W placement will be recorded in the patients surgical records a copy of which will be retained in the patient records. 7. Patients with visually significant cataract who meet the inclusion/exclusion criteria for istent inject W (x3) will have stent placement combined with cataract surgery. Patients without cataract or who've previously undergone cataract surgery who meet the inclusion/exclusion criteria for istent inject W (x3) will have stent placement as a stand-alone procedure.
Sponsors
Colin Clement
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pseudophakic or phakic (with cataract surgery for combined group) 2. Diagnosis of OAG, including primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG), or pseudoexfoliative glaucoma (PXG). 3. Cup-to-Disc (C:D) ratio less than 0.9 4. VF defects with mean deviation ranging from 0 dB to -18dB (inclusive) 5. Mild, moderate, or severe glaucoma severity (per Hodapp-Anderson-Parrish grading scale based on preoperative VF MD) 6. Medicated or unmedicated IOP greater than 7 mmHg and less than 29 mmHg 7. Current treatment with 0 to 4 ocular hypotensive medications 8. Normal angle anatomy as determined by gonioscopy 9. Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stents 10. Planning to undergo or have undergone (within the prior 90 days) trabecular micro-bypass with three iStent inject W stents 11. Able and willing to attend follow-up exams for 12 (or 24) months 12. Able and willing to provide written informed consent
Exclusion criteria
1. Traumatic, uveitic, neovascular, pigmentary, or angle-closure glaucoma; or glaucoma associated with vascular disorders 2. Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis) 3. Significant corneal dystrophy (e.g., bullous keratopathy, Fuch’s dystrophy), guttata, or opacities/disorders preventing angle visualization 4. Corneal surgery (prior or anticipated) of any type (e.g., LASIK, LASEK, PRK, PK, etc.) that may interfere with IOP measurement reliability 5. Angle closure or Shaffer grade < 2 6. Congenital or traumatic cataract 7. Retinal or optic nerve disorders not associated with glaucoma 8. Elevated episcleral venous pressure (e.g., thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital congestion) 9. Chronic or acute ocular inflammation (e.g., uveitis, iritis, retinitis)
Outcome results
None listed