Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery (SAFARI4)

Multicentre, Non-randomised Clinical Study Evaluating the Safety and Efficacy of a Cilioscleral Interposition Device ("CID") v2.2 in Glaucoma Surgery

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

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma, Open-Angle; Glaucoma, Narrow Angle
• Intervention / Treatment: Device: Cilioscleral Interposition Device

Detailed Description

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
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Hospital Clinic of Barcelona
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos. Servicio de Oftalmología
  • Sabadell, Spain, 08205
    • OMIQ Research
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet. Servicio de Oftalmología.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria To be included in the study, all patients must meet all the following inclusion criteria:

Patient:

1. 18 years or older
2. Able to understand study requirements

3. Able and willing:

   1. To provide written consent on the EC-approved Informed Consent Form,
   2. To comply with all study requirements, including required study follow-up visits' agenda

   Eye:

4. Glaucoma (angle from 1 to 4 according to Schaffer grade), including pseudo exfoliative and pigmentary glaucoma, which meets the following:

   1. 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,
   2. Glaucoma visual field with -15 < MD < 0dB (Humphrey) or 0 < MD < 15 dB (Octopus)
5. 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,

6. IOP:

   1. if using 1 or 2 IOP-lowering medications, IOP is between 18 mmHg and 30 mmHg in the study eye at Screening visit
   2. if using 3 IOP-lowering medications, IOP is between 18 mmHg and 25 mmHg in the study eye at Screening visit
7. Having the indication for glaucoma surgery alone (no concomitant cataract surgery)
8. Central Corneal Thickness between 480 to 620 µm
9. 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.

Exclusion criteria Patients will not participate in this clinical study if they meet any of the following criteria:

Patient:

1. Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder
2. Patient already included in another study
3. A person protected by law (temporary or permanent guardianship) or not capable of discernment
4. Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …)
5. Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening)
6. 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, …)
7. 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

8. Chemotherapy in the last 6 months before surgery

   Eye:

9. Inflammatory, congenital, malignant, traumatic, uveitic, neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)
10. Fast progressing or very severe glaucoma or any condition requiring a filtering surgery
11. History of any incisional glaucoma surgery or implantable glaucoma device
12. Prior SLT, ALT or MLT
13. Eye surgery (other than glaucoma) less than 6 months ago, or presenting sequelae of previous eye surgery or trauma
14. Eye with uncontrolled IOP despite 4 IOP-lowering medications prescribed for more than a month
15. Eye with severe OSD and / or severe dry eye defined as Oxford score ≥ 4
16. Inability to obtain accurate IOP measurement throughout the study (e.g. history of corneal surgery, corneal opacities or disease/pathology)
17. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge Weber syndrome, orbital tumors, orbital congestive disease
18. Any known ocular condition that may require intraocular intervention during the protocol required follow-up period
19. Premature or mature cataract (initial cataract are accepted)
20. Any condition that prevents the investigational device implantation in the superior and nasal region of the eye
21. Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications
22. Non laser retinal surgery
23. Previous cyclodestructive or scleral buckling procedure
24. History of complicated cataract surgery (as posterior capsular rupture, vitreous loss)
25. History of silicone oil
26. Ocular steroid in the planned study eye or systemic steroid use in the last 3 months before surgery
27. Use of oral hypotensive glaucoma medications for treatment of the fellow eye
28. Axial length <20 mm
29. Severe myopia defined as spherical correction < -8 Diopters
30. Best corrected distant visual acuity of 0.1 (20/200) or worse in the study or fellow eye
31. Peripheral synechia at the angle
32. Closed angle
33. Peripheral laser iridotomy in the last 7 days before planned surgery
34. Epithelial or fibrous downgrowth
35. Any kind of endothelial dystrophy
36. Severe blepharitis
37. Chronic or recurrent uveitis
38. Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation
39. 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
40. Scleral fixation IOL
41. Lens dislocation or subluxation
42. Vitreous loss in the anterior chamber

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cilioscleral Interposition Device; Any patients corresponding to inclusion / exclusion criteria	Device: Cilioscleral Interposition Device; Surgical placement of SV22 cilioscleral interposition device in the supraciliary space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess post-op IOP reduction	Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline and 6 months after surgery	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medicated IOP and IOP-lowering treatments	Mean change in medicated IOP and IOP-lowering pharmacological treatments	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	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	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	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	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	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	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	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	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	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	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	6, 12, 24 and 36 months after surgery
Surgical implantation evaluation	To evaluate the surgical procedure (duration of operation, ease of implantation)	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	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	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	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	up to 36 months
Safety examination findings	Slit lamp, gonioscopy and fundus findings	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	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	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	6, 12, 24 and 36 months after surgery
Rate of sight threatening events	Rate of sight threatening events	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	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	6, 12, 24 and 36 months after surgery

Collaborators and Investigators

• Sponsor: Ciliatech
• Investigators: Principal Investigator: Julian GARCIA FEIJOO, Pr, Clinica San Carlos

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): April 29, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure
• Other Study ID Numbers: SAFARI 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No