NCT05236439已完成不适用
Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of Supraflow v2.2 in Glaucoma Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ciliatech
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Assess post-op IOP and IOP lowering pharmacological treatments
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in the study, all patients must meet all the following inclusion criteria:
- •18 years or older
- •Able to understand study requirements
- •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
- •Primary Open Angle Glaucoma (POAG) or Narrow Angle Glaucoma (PNAG), including pseudo exfoliative and pigmentary glaucoma, which meets the following:
- •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,
- •Glaucoma visual field (Humphrey) with -15 < MD < 0dB
- •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,
- •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
- •Having the indication for glaucoma surgery alone (no concomitant cataract surgery)
- •Central Corneal Thickness between 480 to 620 µm
- •Gonioscopy confirming normal angle anatomy at site of implantation
排除标准
- •Patients will not participate in this clinical study if they meet any of the following criteria:
- •Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder
- •Patient already included in another study
- •A person protected by law (temporary or permanent guardianship) or not capable of discernment
- •Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …)
- •Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening)
- •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, …)
- •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
- •Chemotherapy in the last 6 months before surgery
- •Inflammatory, congenital, malignant, traumatic, uveitic, neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)
- •History of any incisional glaucoma surgery or implantable glaucoma device
- •Prior SLT, ALT or MLT
- •Eye surgery (other than glaucoma) less than 6 months ago, or presenting sequelae of previous eye surgery or trauma
- •Inability to obtain accurate IOP measurement throughout the study (e.g. history of corneal surgery, corneal opacities or disease/pathology)
- •Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease
- •Any known ocular condition that may require intraocular intervention during the protocol required follow-up period
- •Premature or mature cataract (initial cataract are accepted)
- •Any condition that prevents the investigational device implantation in the superior and nasal region of the eye
- •Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications
- •Non laser retinal surgery
- •Previous cyclodestructive or scleral buckling procedure
- •History of complicated cataract surgery (as posterior capsular rupture, vitreous loss)
- •History of silicone oil
- •Ocular steroid in the planned study eye or systemic steroid use in the last 3 months before surgery
- •Use of oral hypotensive glaucoma medications for treatment of the fellow eye
- •Axial length <20 mm
- •Severe myopia
- •Best corrected distant visual acuity of 0.1 (20/200) or worse in the study or fellow eye
- •Peripheral synechia at the angle
- •Closed angle
- •Peripheral laser iridotomy in the last 7 days before planned surgery
- •Epithelial or fibrous downgrowth
- •Severe dry eye syndrome
- •Severe blepharitis
- •Chronic or recurrent uveitis
- •Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation
- •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
- •Scleral fixation IOL
- •Lens dislocation or subluxation
- •Vitreous loss in the anterior chamber
研究组 & 干预措施
Interposition supraciliary implant
Experimental
Any patients corresponding to inclusion / exclusion criteria
干预措施: Interposition supraciliary implant (Device)
结局指标
主要结局
Assess post-op IOP and IOP lowering pharmacological treatments
时间窗: 24 months
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 24 months after surgery
Assess post-op IOP and IOP lowering pharmacological treatments
时间窗: 24 months
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 24 months after surgery
次要结局
- Assess post op mean diurnal IOP(up to 36 months)
- Assess mean medicated IOP(Up to 36 months)
- Mean number of IOP lowering pharmacological treatments(Up to 36 months)
- Mean change in post op IOP and IOP lowering pharmacological treatment(6, 12, 18, and 36 months)
- Assess absolute success rate(Up to 36 months)
- Assess qualified success rate(Up to 36 months)
- Rate of patients with a reduction in post operative IOP(Up to 36 months)
- Proportion of eyes free of ocular hypotensive medications(Up to 36 months)
- Assess proportion of eyes with IOP between 6-18 mmHg(Up to 36 months)
- Proportion of eyes with IOP between 6-16 mmHg(Up to 36 months)
- Average number of adjunctive therapies post-operatively(Up to 36 months)
- Rate of patients with no filtering blebs(Up to 36 months)
- Assess the surgical procedure(Day 0, day of surgery)
- Assess patient satisfaction post-operatively(Up to 36 months)
- Describe patient's quality of life(Up to 36 months)
- Assess rate of intraoperative and post-operative related adverse device effects(Up to 36 months)
- Review slit lamp, gonioscopy and fundus findings(Up to 36 months)
- Determine rate of BCVA(Up to 36 months)
- Assess rate of Visual field mean deviation variation (VF MD)(Up to 36 months)
- Determine rate of C/D ratio mean deviation(Up to 36 months)
- Assess rate of sight threatening events(Up to 36 months)
- Assess rate of change in endothelial cell density and central corneal thickness(Up to 36 months)
- Assess rate of occurrence of SV22 movements in the supraciliary space(Up to 36 months)
- Assess post op mean diurnal IOP(up to 36 months)
- Assess mean medicated IOP(Up to 36 months)
- Mean number of IOP lowering pharmacological treatments(Up to 36 months)
- Mean change in post op IOP and IOP lowering pharmacological treatment(6, 12, 18, and 36 months)
- Assess absolute success rate(Up to 36 months)
- Assess qualified success rate(Up to 36 months)
- Rate of patients with a reduction in post operative IOP(Up to 36 months)
- Proportion of eyes free of ocular hypotensive medications(Up to 36 months)
- Assess proportion of eyes with IOP between 6-18 mmHg(Up to 36 months)
- Proportion of eyes with IOP between 6-16 mmHg(Up to 36 months)
- Average number of adjunctive therapies post-operatively(Up to 36 months)
- Rate of patients with no filtering blebs(Up to 36 months)
- Assess the surgical procedure(Day 0, day of surgery)
- Assess patient satisfaction post-operatively(Up to 36 months)
- Describe patient's quality of life(Up to 36 months)
- Assess rate of intraoperative and post-operative related adverse device effects(Up to 36 months)
- Review slit lamp, gonioscopy and fundus findings(Up to 36 months)
- Determine rate of BCVA(Up to 36 months)
- Assess rate of Visual field mean deviation variation (VF MD)(Up to 36 months)
- Determine rate of C/D ratio mean deviation(Up to 36 months)
- Assess rate of sight threatening events(Up to 36 months)
- Assess rate of change in endothelial cell density and central corneal thickness(Up to 36 months)
- Assess rate of occurrence of SV22 movements in the supraciliary space(Up to 36 months)
研究者
研究点 (2)
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