Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma and Narrow Angle Glaucoma
- Conditions
- Glaucoma, Open-AngleGlaucoma, Narrow Angle
- Registration Number
- NCT05236439
- Lead Sponsor
- Ciliatech
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Malayan center
🇦🇲Yerevan, Yerevan, Armenia
Malayan center🇦🇲Yerevan, Yerevan, Armenia