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 and narrow angle glaucoma who have failed at least one class of topical medical therapy
29 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
29
Surgical placement of SV22 cilioscleral interposition device in the supraciliary space
Hospital Clínic of Barcelona
Barcelona, Spain
RECRUITINGHospital Universitario Ramón y Cajal
Madrid, Spain
WITHDRAWNHospital Clínico San Carlos. Servicio de Oftalmología
Madrid, Spain
Assess post-op IOP reduction
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline and 6 months after surgery
Time frame: 6 months
Change in medicated IOP and IOP-lowering treatments
Mean change in medicated IOP and IOP-lowering pharmacological treatments
Time frame: baseline and 12, 24, and 26 months after surgery
Decrease in IOP from baseline up to 36 months post-operatively
Proportion of eyes with greater than or equal to 20% decrease in IOP from baseline up to 36 months post-operatively with IOP lowering medication
Time frame: baseline up to 6, 12, 24, and 36 months post-operatively
Mean medicated IOP
Mean medicated IOP at baseline and up to 36 months after surgery
Time frame: baseline, 6, 12, 24, and 36 months after surgery
Mean number of IOP lowering treatments
Mean number of IOP lowering pharmacological treatments at baseline and up to 36 months after surgery
Time frame: baseline, 6, 12, 24, and 36 months after surgery
Absolute success rate: proportion of med-free eyes
Proportion of med-free eyes with IOP decrease of greater than or equal to 20% from baseline and below 18 mmHg up to 36 months after surgery
Time frame: 6, 12, 24, and 36 months
Qualified success rate: proportion of eyes with IOP decrease
Proportion of eyes with IOP decrease of greater than or equal to 20% from baseline and below 18 mmHg up to 36 months after surgery
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OMIQ Research
Sabadell, Spain
RECRUITINGHospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
RECRUITINGHospital Universitario Miguel Servet. Servicio de Oftalmología.
Zaragoza, Spain
RECRUITINGTime frame: 6, 12, 24, 36 months
Rate of patients with reduction of IOP at each visit
Rate of patients with at least a 20%, 30%, 40% and more than 50% reduction in IOP at each visit vs baseline, with and without IOP lowering pharmacological treatments
Time frame: 36 months
Proportion of eyes free of ocular hypertensives
Proportion of eyes free of ocular hypotensive medications at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24, and 36 months after surgery
Proportion of eyes with IOP between 6 and 18 mmHg with and without IOP lowering treatments
Proportion of eyes with IOP ≥6 mmHg and ≤ 18 mmHg, with and without IOP-lowering pharmacological treatments at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24 and 36 months after surgery
Proportion of eyes with IOP between 6 and 16 mmHg with and without IOP lowering treatments
Proportion of eyes with IOP ≥6 mmHg and ≤ 16 mmHg, with and without IOP-lowering pharmacological treatments at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24 and 36 months after surgery
Number of adjunctive therapies
Average number of adjunctive therapies (needling, goniopuncture, SLT, …) performed up to 36 months postoperatively
Time frame: 36 months
Patient rate without filtering bleb
Rate of patients without filtering bleb, average duration of filtering blebs at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24 and 36 months after surgery
Surgical implantation evaluation
To evaluate the surgical procedure (duration of operation, ease of implantation)
Time frame: 1 day
Assess patient experience post-operatively
To describe patient experience following surgery using questions asked by the surgeon, for pain (Yes/No), quality of vision (deteriorated, stable, improved) and sensation in the eye (discomfort / nothing to declare) at 1 and 7 days, then at 1, 6, 12, 24 and 36 months after surgery
Time frame: 1 and 7 days, then at 1, 6, 12, 24 and 36 months after surgery
Describe patient satisfaction post-operatively
To describe patient satisfaction following surgery using questionnaires (VAS scale) for comfort and satisfaction at 1, 6, 12, 24 and 36 months after surgery
Time frame: 1, 6, 12, 24 and 36 months after surgery
Assess patient quality of life
To describe changes in quality of life using EQ5D-5L questionnaire at 1, 6, 12, 24 and 36 months after surgery
Time frame: 1, 6, 12, 24 and 36 months after surgery
Rate of device related ocular adverse events and adverse device effects
Rate of intraoperative and post-operative device related ocular adverse events and adverse device effects
Time frame: up to 36 months
Safety examination findings
Slit lamp, gonioscopy and fundus findings
Time frame: up to 36 months
Rate of Best Corrected Visual Acuity
Rate of Best Corrected Visual Acuity variation (BCVA) at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24 and 36 months after surgery
Rate of Visual Field Mean Deviation variation
Rate of Visual Field Mean Deviation variation (VF MD) at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24 and 36 months after surgery
Rate of C/D ratio mean deviation
Rate of C/D ratio mean deviation at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24 and 36 months after surgery
Rate of sight threatening events
Rate of sight threatening events
Time frame: up to 36 months
Rate of change in endothelial cell density (ECD) and central corneal thickness (CCT)
Rate of change in endothelial cell density (ECD) and central corneal thickness (CCT) at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24 and 36 months after surgery
Rate of occurrence of SUPRAFLOW V2.2 movements
Rate of occurrence of SUPRAFLOW V2.2 movements inside the supraciliary space at 6, 12, 24 and 36 months after surgery
Time frame: 6, 12, 24 and 36 months after surgery