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Active, not recruitingNCT05625958SAFARI4Updated Apr 22, 2026

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

An interventional study of Cilioscleral Interposition Device in Glaucoma, Open-Angle and Glaucoma, Narrow Angle, sponsored by Ciliatech. Active, not recruiting at 5 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Ciliatech · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Glaucoma, Open-Angle
  • Glaucoma, Narrow Angle
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 29 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Ciliatech is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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 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 : 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, 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 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (estimated)

Study arms

  • Experimental
    Cilioscleral Interposition Device

    Any patients corresponding to inclusion / exclusion criteria

    Device: Cilioscleral Interposition Device

Interventions

  • DeviceCilioscleral Interposition Device

    Surgical placement of SV22 cilioscleral interposition device in the supraciliary space

06

What researchers measure

Primary outcomes

  1. Assess post-op IOP reduction

    Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline and 6 months after surgery

    Time frame: 6 months

Secondary outcomes

  1. Change in medicated IOP and IOP-lowering treatments

    Mean change in medicated IOP and IOP-lowering pharmacological treatments

    Time frame: baseline and 12, 24, and 26 months after surgery

  2. 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

    Time frame: baseline up to 6, 12, 24, and 36 months post-operatively

  3. Mean medicated IOP

    Mean medicated IOP at baseline and up to 36 months after surgery

    Time frame: baseline, 6, 12, 24, and 36 months after surgery

  4. Mean number of IOP lowering treatments

    Mean number of IOP lowering pharmacological treatments at baseline and up to 36 months after surgery

    Time frame: baseline, 6, 12, 24, and 36 months after surgery

  5. 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

    Time frame: 6, 12, 24, and 36 months

  6. 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

    Time frame: 6, 12, 24, 36 months

  7. 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

    Time frame: 36 months

  8. Proportion of eyes free of ocular hypertensives

    Proportion of eyes free of ocular hypotensive medications at 6, 12, 24 and 36 months after surgery

    Time frame: 6, 12, 24, and 36 months after surgery

  9. 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

    Time frame: 6, 12, 24 and 36 months after surgery

  10. 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

    Time frame: 6, 12, 24 and 36 months after surgery

  11. Number of adjunctive therapies

    Average number of adjunctive therapies (needling, goniopuncture, SLT, …) performed up to 36 months postoperatively

    Time frame: 36 months

  12. 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

    Time frame: 6, 12, 24 and 36 months after surgery

  13. Surgical implantation evaluation

    To evaluate the surgical procedure (duration of operation, ease of implantation)

    Time frame: 1 day

  14. 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

    Time frame: 1 and 7 days, then at 1, 6, 12, 24 and 36 months after surgery

  15. 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

    Time frame: 1, 6, 12, 24 and 36 months after surgery

  16. 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

    Time frame: 1, 6, 12, 24 and 36 months after surgery

  17. 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

    Time frame: up to 36 months

  18. Safety examination findings

    Slit lamp, gonioscopy and fundus findings

    Time frame: up to 36 months

  19. Rate of Best Corrected Visual Acuity

    Rate of Best Corrected Visual Acuity variation (BCVA) at 6, 12, 24 and 36 months after surgery

    Time frame: 6, 12, 24 and 36 months after surgery

  20. 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

    Time frame: 6, 12, 24 and 36 months after surgery

  21. Rate of C/D ratio mean deviation

    Rate of C/D ratio mean deviation at 6, 12, 24 and 36 months after surgery

    Time frame: 6, 12, 24 and 36 months after surgery

  22. Rate of sight threatening events

    Rate of sight threatening events

    Time frame: up to 36 months

  23. 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

    Time frame: 6, 12, 24 and 36 months after surgery

  24. 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

    Time frame: 6, 12, 24 and 36 months after surgery

07

Study locations

5 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Apr 2026, 37 months after the start.

Of 70 industry-sponsored interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 37 months is above that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2022
First posted
Nov 23, 2022
StartActual
Mar 23, 2023
Primary completionEst.
Apr 29, 2026
CompletionEst.
Sep 1, 2028
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05625958
Lead sponsor
Ciliatech
Responsible party
Sponsor
First posted
Nov 23, 2022
Start date
Mar 23, 2023
Primary completion
Apr 29, 2026 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Apr 22, 2026

Study contacts

Julian GARCIA FEIJOO, Pr
principal investigator · Clinica San Carlos

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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