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

NCT ID: NCT05625958

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2028-09-01

Brief Summary

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

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.

Conditions

Glaucoma, Open-Angle; Glaucoma, Narrow Angle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cilioscleral Interposition Device

Any patients corresponding to inclusion / exclusion criteria

Group Type: EXPERIMENTAL

Cilioscleral Interposition Device

Intervention Type: DEVICE

Surgical placement of SV22 cilioscleral interposition device in the supraciliary space

Interventions

Cilioscleral Interposition Device

Surgical placement of SV22 cilioscleral interposition device in the supraciliary space

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ciliatech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian GARCIA FEIJOO, Pr

Role: PRINCIPAL_INVESTIGATOR

Clinica San Carlos

Locations

Hospital Clínic of Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status: WITHDRAWN

Hospital Clínico San Carlos. Servicio de Oftalmología

Madrid, , Spain

Site Status: RECRUITING

OMIQ Research

Sabadell, , Spain

Site Status: RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status: RECRUITING

Hospital Universitario Miguel Servet. Servicio de Oftalmología.

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Stephanie JONES

Role: CONTACT

s.jones@cilia.tech

2018146271

Facility Contacts

Enrique Ordiñaga-Monreal

Role: primary

ordinaga@recerca.clinic.cat

+34 932 27 54 00

Ainhoa Colina

Role: primary

ainhoacolina.hcsc@gmail.com

+34 91 330 3000 ext. 2742

Marc Biarnés

Role: primary

mbiarnes@omiq.es

+34 690 795 052

Carlos Gómez

Role: primary

cgomezhcu@gmail.com

+34 976 556 400 ext. 164262

Beatriz Cameo

Role: primary

beacameo@hotmail.com

+34 976 76 55 00

Other Identifiers

SAFARI 4

Identifier Type: -

Identifier Source: org_study_id