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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Surgical placement of SV22 interposition supraciliary implant in the supraciliary space
Malayan center
Yerevan, Yerevan, Armenia
Assess post-op IOP and IOP lowering pharmacological treatments
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 24 months after surgery
Time frame: 24 months
Assess post op mean diurnal IOP
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
Time frame: up to 36 months
Assess mean medicated IOP
Mean medicated IOP at Baseline and 6, 12, 18, 24 and 36 months after surgery
Time frame: Up to 36 months
Mean number of IOP lowering pharmacological treatments
Mean number of IOP-lowering pharmacological treatments at baseline and 6, 12, 18, 24 and 36 months after surgery
Time frame: Up to 36 months
Mean change in post op IOP and IOP lowering pharmacological treatment
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 6, 12, 18 and 36 months after surgery
Time frame: 6, 12, 18, and 36 months
Assess absolute success rate
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
Time frame: Up to 36 months
Assess qualified success rate
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
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Time frame: Up to 36 months
Rate of patients with a reduction in post operative IOP
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
Time frame: Up to 36 months
Proportion of eyes free of ocular hypotensive medications
Proportion of eyes free of ocular hypotensive medications at 6, 12, 18, 24 and 36 months after surgery
Time frame: Up to 36 months
Assess proportion of eyes with IOP between 6-18 mmHg
Proportion of eyes with IOP ≥6 mmHg and ≤ 18 mmHg, the same with med-free eyes only
Time frame: Up to 36 months
Proportion of eyes with IOP between 6-16 mmHg
Proportion of eyes with IOP ≥6 mmHg and ≤ 16 mmHg, the same with med-free eyes only
Time frame: Up to 36 months
Average number of adjunctive therapies post-operatively
Average number of adjunctive therapies (needling, goniopuncture, SLT, …) performed up to 36 months postoperatively
Time frame: Up to 36 months
Rate of patients with no filtering blebs
Rate of patients with no filtering bleb, average duration of filtering blebs
Time frame: Up to 36 months
Assess the surgical procedure
To evaluate the surgical procedure (duration of operation, ease of implantation)
Time frame: Day 0, day of surgery
Assess patient satisfaction post-operatively
To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity
Time frame: Up to 36 months
Describe patient's quality of life
To describe changes in quality of life (EQ5D)
Time frame: Up to 36 months
Assess rate of intraoperative and post-operative related adverse device effects
Rate of intraoperative and post-operative device related ocular adverse events and adverse device effect
Time frame: Up to 36 months
Review slit lamp, gonioscopy and fundus findings
Slit lamp, gonioscopy and fundus findings
Time frame: Up to 36 months
Determine rate of BCVA
Rate of best corrected visual acuity variation (BCVA)
Time frame: Up to 36 months
Assess rate of Visual field mean deviation variation (VF MD)
Rate of Visual field mean deviation variation (VF MD)
Time frame: Up to 36 months
Determine rate of C/D ratio mean deviation
Rate of C/D ratio mean deviation
Time frame: Up to 36 months
Assess rate of sight threatening events
Rate of sight threatening events
Time frame: Up to 36 months
Assess rate of change in endothelial cell density and central corneal thickness
Rate of change in endothelial cell density (ECD) and central corneal thickness (CCT)
Time frame: Up to 36 months
Assess rate of occurrence of SV22 movements in the supraciliary space
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
Time frame: Up to 36 months