Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery

Korábbi kezelés

• 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
  • Eye:
• 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
• Any condition that prevents the investigational device implantation in the superior and nasal region of the eye
• Non laser retinal surgery
• Previous cyclodestructive or scleral buckling procedure
• 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
• Peripheral laser iridotomy in the last 7 days before planned surgery

Más betegség

• Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder
• 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, …)
• 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
• 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
• History of complicated cataract surgery (as posterior capsular rupture, vitreous loss)
• History of silicone oil
• 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

Laborértékek

• Prior SLT, ALT or MLT

Egyéb

• Patient:
• 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)
• Eye with severe OSD and / or severe dry eye defined as Oxford score ≥ 4
• Premature or mature cataract (initial cataract are accepted)
• Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications
• 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
• Epithelial or fibrous downgrowth
• Any kind of endothelial dystrophy
• Severe blepharitis
• Chronic or recurrent uveitis
• Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation
• Scleral fixation IOL
• Lens dislocation or subluxation
• Vitreous loss in the anterior chamber

• Patient:
• 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
  • Eye:
• 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,
• IOP:
  • 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.