NCT05625958进行中（未招募）不适用
Multicentre, Non-randomised Clinical Study Evaluating the Safety and Efficacy of a Cilioscleral Interposition Device ("CID") v2.2 in Glaucoma Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ciliatech
- 入组人数
- 29
- 试验地点
- 11
- 主要终点
- Assess post-op IOP reduction
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 and narrow angle glaucoma who have failed at least one class of topical medical therapy
详细描述
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.
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,
- •To comply with all study requirements, including required study follow-up visits' agenda
- •Glaucoma (angle from 1 to 4 according to Schaffer grade), 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 with -15 < MD < 0dB (Humphrey) or 0 < MD < 15 dB (Octopus)
- •Pharmacological treatments: glaucoma not adequately controlled by 1 to 3 different IOP-lowering medication(s), given each for at least one month prior to Screening,
- •if using 1 or 2 IOP-lowering medications, IOP is between 18 mmHg and 30 mmHg in the study eye at Screening visit
- •if using 3 IOP-lowering medications, IOP is between 18 mmHg and 25 mmHg in the study eye at Screening visit
- •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. Angle anatomy may include Peripheral Anterior Synechiae (PAS) of up to maximum of 3 clock hours if not present parallel to the proposed site of device 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)
- •Fast progressing or very severe glaucoma or any condition requiring a filtering surgery
- •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
- •Eye with uncontrolled IOP despite 4 IOP-lowering medications prescribed for more than a month
- •Eye with severe OSD and / or severe dry eye defined as Oxford score ≥ 4
- •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 defined as spherical correction < -8 Diopters
- •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
- •Any kind of endothelial dystrophy
- •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
Cilioscleral Interposition Device
Experimental
Any patients corresponding to inclusion / exclusion criteria
干预措施: Cilioscleral Interposition Device (Device)
结局指标
主要结局
Assess post-op IOP reduction
时间窗: 6 months
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline and 6 months after surgery
Assess post-op IOP reduction
时间窗: 6 months
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline and 6 months after surgery
次要结局
- Change in medicated IOP and IOP-lowering treatments(baseline and 12, 24, and 26 months after surgery)
- Decrease in IOP from baseline up to 36 months post-operatively(baseline up to 6, 12, 24, and 36 months post-operatively)
- Mean medicated IOP(baseline, 6, 12, 24, and 36 months after surgery)
- Mean number of IOP lowering treatments(baseline, 6, 12, 24, and 36 months after surgery)
- Absolute success rate: proportion of med-free eyes(6, 12, 24, and 36 months)
- Qualified success rate: proportion of eyes with IOP decrease(6, 12, 24, 36 months)
- Rate of patients with reduction of IOP at each visit(36 months)
- Proportion of eyes free of ocular hypertensives(6, 12, 24, and 36 months after surgery)
- Proportion of eyes with IOP between 6 and 18 mmHg with and without IOP lowering treatments(6, 12, 24 and 36 months after surgery)
- Proportion of eyes with IOP between 6 and 16 mmHg with and without IOP lowering treatments(6, 12, 24 and 36 months after surgery)
- Number of adjunctive therapies(36 months)
- Patient rate without filtering bleb(6, 12, 24 and 36 months after surgery)
- Surgical implantation evaluation(1 day)
- Assess patient experience post-operatively(1 and 7 days, then at 1, 6, 12, 24 and 36 months after surgery)
- Describe patient satisfaction post-operatively(1, 6, 12, 24 and 36 months after surgery)
- Assess patient quality of life(1, 6, 12, 24 and 36 months after surgery)
- Rate of device related ocular adverse events and adverse device effects(up to 36 months)
- Safety examination findings(up to 36 months)
- Rate of Best Corrected Visual Acuity(6, 12, 24 and 36 months after surgery)
- Rate of Visual Field Mean Deviation variation(6, 12, 24 and 36 months after surgery)
- Rate of C/D ratio mean deviation(6, 12, 24 and 36 months after surgery)
- Rate of sight threatening events(up to 36 months)
- Rate of change in endothelial cell density (ECD) and central corneal thickness (CCT)(6, 12, 24 and 36 months after surgery)
- Rate of occurrence of SUPRAFLOW V2.2 movements(6, 12, 24 and 36 months after surgery)
研究者
研究点 (11)
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