Glaucoma, Open-Angle
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy
Detailed description
22 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 novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices. Several patient data like 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 2 interposition supraciliary implant in the supraciliary space
Sponsors
Clinchoice Inc
Ciliatech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient: 1. Patient ≥ 50 years old 2. Patient dated and signed the informed consent form to participate in the study at first visit Eye: 3. Phakic, pseudophakic or aphakic eye 4. Has medically treated open-angle glaucoma (schaffer grade 3 and 4) 5. The optimal medical treatment against glaucoma for this eye has failed i. Preoperative treatment ≥ 2 molecules with target IOP not reached despite medication, ii. or IOP ≥ 21 mmHg under treatment, iii. or patient not compliant with treatment, iv. or patient intolerant to treatment 6. Having undergone at most one filtration surgery (trabeculectomy, deep sclerectomy, viscocanalostomy) for more than 3 months. 7. Having the indication for glaucoma surgery alone
Exclusion criteria
Patient: 1. Patient with visual acuity of the contralateral eye greater than LogMar 0.3. If no problems are detected at three months post surgery on at least the first 10 patients included, the study monitoring committee may propose to relax this non-inclusion criterion by setting the visual acuity of the contralateral eye above LogMar 0.7 2. Patient with a known allergy to any of the constituents of the products used in this study 3. Patient already included in another study 4. A person protected by law (temporary or permanent guardianship) or not capable of discernment Eye 5. Presenting with inflammatory glaucoma 6. Presenting with congenital glaucoma 7. Presenting with major traumatic glaucoma or neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome) 8. Having had a non-surgical operational treatment (ultrasound, cyclophotocoagulation, etc.) 9. Having had eye surgery (other than glaucoma) less than 6 months ago 10. Closed angle, grade 1 or 2 Schafer OAG 11. Pre-existing ocular or systemic pathology that may cause post operative complications such as: * Clinically significant inflammation such as uveitis * Eye infection * Anterior segment neovascular disease 12. Severe dry eye syndrome 13. Severe blepharitis 14. Retinopathy which can lead to neovascular complications in the anterior segment 15. Eye of axial length \<20 mm 16. Eye with lens dislocation or subluxation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess post-op IOP reduction | 6, 12, 24, 26, 48, 60 months | Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% |
| Assess post-op IOP clinical success | 6, 12, 24, 26, 48, 60 months | Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assess rate of patients with a reduction in post-op IOP with or without combined treatments | Up to 60 months | To describe the rate of patients with at least a 20%, 25%, 30% and 40% reduction in postoperative IOP, with or without combined medical treatments, at each visit |
| assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold | Up to 60 months | To describe the rate of patients with a post-operative IOP ≤ 18 mm Hg; as well as for a threshold ≤ 16 mm Hg |
| assess the rate of patients with a reduction of IOP post-operatively | Up to 60 months | To describe the rate of patients with a reduction of post-operative IOP of least 5 mmHg |
| assess the mean and median reduction in IOP | Up to 60 months | To describe the mean and median reduction in IOP between the baseline and each subsequent assessment |
| assess the rate of patients without medical treatment for glaucoma | Up to 60 months | To describe the rate of patients without medical treatment for glaucoma at each visit |
| average rate of IOP reduction | Up to 60 months | describe the average rate of IOP reduction vs baseline |
| Evaluate implant and surgical procedure safety | up to 60 months | To evaluate the safety of the implant and the surgical procedure: To describe of all adverse events (AEs) throughout the study |
| assess the rate of patients with no filtering bleb | Up to 60 months | To describe the rate of patients with no filtering bleb |
| Average number of adjunctive therapies and follow up visits | Up to 60 months | To describe the average number of adjunctive therapies (needling, goniopuncture) and follow up visits (including those which were scheduled and which were not scheduled in the protocol) |
| Evaluate surgical procedure | Day 0, day of surgery | To evaluate the surgical procedure (duration of operation, ease of implantation) |
| Assess patient satisfaction | Up to 60 months | To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity |
| Assess changes in quality of life | Up to 60 months | To describe changes in quality of life (EQ5D) |
| Follow the progression of glaucoma and potential complications | Up to 60 months | To describe the progression of the glaucoma at 6, 12, 24, 36, 48 and 60 months, and any complications |
| assess IOP stability | Up to 60 months | To describe IOP stability over at each visit, without further eye surgery, and without the use of anti-glaucoma or adjunctive therapies such as goniopuncture or needling |
| Compare clinical success rate | Up to 60 months | To compare the clinical success rate at 6, 12, 24, 36, 48 and 60 months to that of the Supraflow study in Armenia |
Countries
Armenia
Outcome results
None listed