Glaucoma, Narrow Angle, Glaucoma, Open-Angle
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy
Detailed description
57 patients will be included in this 36 months interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device. Several patient data like safety events, IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up. Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.
Interventions
Surgical placement of SV22 interposition supraciliary implant in the supraciliary space
Sponsors
Ciliatech
Clinchoice Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in the study, all patients must meet all the following inclusion criteria: Patient: 1. 18 years or older 2. Able to understand study requirements 3. Able and willing: To provide written consent on the EC-approved Informed Consent Form, b. To comply with all study requirements, including required study follow-up visits' agenda Eye: 4. Primary Open Angle Glaucoma (POAG) or Narrow Angle Glaucoma (PNAG), including pseudo exfoliative and pigmentary glaucoma, which meets the following: 1. Vertical C/D ratio on fundoscopic exam ≤ 0.9, or OCT demonstrating a thinness of the nerve fibre layer at the p\<5% level as defined by the instrument's built in age-adjusted normative database, 2. Glaucoma visual field (Humphrey) with -15 \< MD \< 0dB 5. Pharmacological treatments: glaucoma not adequately controlled by 1 to 4 different IOP-lowering medication(s), given each for at least one month prior to Screening, 6. IOP: if using 1 to 4 IOP-lowering medication, IOP is between 21 mmHg and 35 mmHg in the study eye at Screening and Baseline visits 7. Having the indication for glaucoma surgery alone (no concomitant cataract surgery) 8. Central Corneal Thickness between 480 to 620 µm 9. Gonioscopy confirming normal angle anatomy at site of implantation
Exclusion criteria
Patients will not participate in this clinical study if they meet any of the following criteria: Patient: 1. Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder 2. Patient already included in another study 3. A person protected by law (temporary or permanent guardianship) or not capable of discernment 4. Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …) 5. Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening) 6. With uncontrolled systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent the subject from completing all study visits (e.g. inability to reliably complete visual field testing over the course of the study, or take glaucoma medications (e.g. Parkinson's disease), or uncontrolled systemic disease (diabetes, hypertension) that could compromise participation in the study, …) 7. Who have a new or modified prescription for a systemic treatment that could influence IOP within one month prior to inclusion, or who are aware of a future change in their systemic treatment, or if their medical condition indicates that their systemic treatment may change in the future 8. Chemotherapy in the last 6 months before surgery Eye: 9. Inflammatory, congenital, malignant, traumatic, uveitic, neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome) 10. History of any incisional glaucoma surgery or implantable glaucoma device 11. Prior SLT, ALT or MLT 12. Eye surgery (other than glaucoma) less than 6 months ago, or presenting sequelae of previous eye surgery or trauma 13. Inability to obtain accurate IOP measurement throughout the study (e.g. history of corneal surgery, corneal opacities or disease/pathology) 14. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease 15. Any known ocular condition that may require intraocular intervention during the protocol required follow-up period 16. Premature or mature cataract (initial cataract are accepted) 17. Any condition that prevents the investigational device implantation in the superior and nasal region of the eye 18. Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications 19. Non laser retinal surgery 20. Previous cyclodestructive or scleral buckling procedure 21. History of complicated cataract surgery (as posterior capsular rupture, vitreous loss) 22. History of silicone oil 23. Ocular steroid in the planned study eye or systemic steroid use in the last 3 months before surgery 24. Use of oral hypotensive glaucoma medications for treatment of the fellow eye 25. Axial length \<20 mm 26. Severe myopia 27. Best corrected distant visual acuity of 0.1 (20/200) or worse in the study or fellow eye 28. Peripheral synechia at the angle 29. Closed angle 30. Peripheral laser iridotomy in the last 7 days before planned surgery 31. Epithelial or fibrous downgrowth 32. Severe dry eye syndrome 33. Severe blepharitis 34. Chronic or recurrent uveitis 35. Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation 36. Active iris neovascularization, rubeosis, proliferative retinopathy, diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders), vitreous haemorrhage, preretinal haemorrhage, choroidopathy or other ophthalmic disease that could confound study results 37. Scleral fixation IOL 38. Lens dislocation or subluxation 39. Vitreous loss in the anterior chamber
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess post-op IOP and IOP lowering pharmacological treatments | 24 months | Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 24 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess post op mean diurnal IOP | up to 36 months | Proportion of eyes with ≥ 20% decrease in mean-Diurnal-IOP from baseline up to 6, 12, 18, 24 and 36 months post-operatively with IOP lowering medication |
| Assess mean medicated IOP | Up to 36 months | Mean medicated IOP at Baseline and 6, 12, 18, 24 and 36 months after surgery |
| Mean number of IOP lowering pharmacological treatments | Up to 36 months | Mean number of IOP-lowering pharmacological treatments at baseline and 6, 12, 18, 24 and 36 months after surgery |
| Mean change in post op IOP and IOP lowering pharmacological treatment | 6, 12, 18, and 36 months | Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 6, 12, 18 and 36 months after surgery |
| Assess absolute success rate | Up to 36 months | Absolute success rate: proportion of med-free eyes with ≥ 20% decrease from baseline and below 18 mmHg at 6, 12, 18, 24 and 36 months after surgery |
| Assess qualified success rate | Up to 36 months | Qualified success rate: proportion of eyes with ≥ 20% decrease from baseline and below 18 mmHg at 6, 12, 18, 24 and 36 months after surgery |
| Rate of patients with a reduction in post operative IOP | Up to 36 months | Rate of patients with at least a 20%, 30%, 40% and more than 50% reduction in post operative IOP, with or without combined medical treatments, at each visit |
| Proportion of eyes free of ocular hypotensive medications | Up to 36 months | Proportion of eyes free of ocular hypotensive medications at 6, 12, 18, 24 and 36 months after surgery |
| Assess proportion of eyes with IOP between 6-18 mmHg | Up to 36 months | Proportion of eyes with IOP ≥6 mmHg and ≤ 18 mmHg, the same with med-free eyes only |
| Proportion of eyes with IOP between 6-16 mmHg | Up to 36 months | Proportion of eyes with IOP ≥6 mmHg and ≤ 16 mmHg, the same with med-free eyes only |
| Average number of adjunctive therapies post-operatively | Up to 36 months | Average number of adjunctive therapies (needling, goniopuncture, SLT, …) performed up to 36 months postoperatively |
| Rate of patients with no filtering blebs | Up to 36 months | Rate of patients with no filtering bleb, average duration of filtering blebs |
| Assess the surgical procedure | Day 0, day of surgery | To evaluate the surgical procedure (duration of operation, ease of implantation) |
| Assess patient satisfaction post-operatively | Up to 36 months | To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity |
| Describe patient's quality of life | Up to 36 months | To describe changes in quality of life (EQ5D) |
| Assess rate of intraoperative and post-operative related adverse device effects | Up to 36 months | Rate of intraoperative and post-operative device related ocular adverse events and adverse device effect |
| Review slit lamp, gonioscopy and fundus findings | Up to 36 months | Slit lamp, gonioscopy and fundus findings |
| Determine rate of BCVA | Up to 36 months | Rate of best corrected visual acuity variation (BCVA) |
| Assess rate of Visual field mean deviation variation (VF MD) | Up to 36 months | Rate of Visual field mean deviation variation (VF MD) |
| Determine rate of C/D ratio mean deviation | Up to 36 months | Rate of C/D ratio mean deviation |
| Assess rate of sight threatening events | Up to 36 months | Rate of sight threatening events |
| Assess rate of change in endothelial cell density and central corneal thickness | Up to 36 months | Rate of change in endothelial cell density (ECD) and central corneal thickness (CCT) |
| Assess rate of occurrence of SV22 movements in the supraciliary space | Up to 36 months | Rate of occurrence of SV22 movements inside the supraciliary space (SCS), defined as a change of position of the anterior edge of the implant of at least 200 µm measured on UBM from D7 to any timepoint |
Countries
Armenia
Contacts
PRINCIPAL_INVESTIGATORLilit Voskanyan
Malayan Center
Outcome results
None listed