An interventional study of Interposition supraciliary implant in Glaucoma, Open-Angle and Glaucoma, Narrow Angle, sponsored by Ciliatech. Completed at 1 site in Armenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Ciliatech · Not applicable, Interventional, and Treatment
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 angle glaucoma (POAG) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy
57 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.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's enrollment of 57 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be included in the study, all patients must meet all the following inclusion criteria:
Patient:
Able and willing:
To provide written consent on the EC-approved Form, b. To comply with all study requirements, including required study follow-up visits' agenda
Eye:
Primary Open Angle Glaucoma (POAG) or Narrow Angle Glaucoma (PNAG), including pseudo exfoliative and pigmentary glaucoma, which meets the following:
Exclusion criteria
Patients will not participate in this clinical study if they meet any of the following criteria:
Patient:
Chemotherapy in the last 6 months before surgery
Eye:
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Any patients corresponding to inclusion / exclusion criteria
Device: Interposition supraciliary implant
Surgical placement of SV22 interposition supraciliary implant in the supraciliary space
Assess post-op IOP and IOP lowering pharmacological treatments
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 24 months after surgery
Time frame: 24 months
Assess post op mean diurnal IOP
Proportion of eyes with ≥ 20% decrease in mean-Diurnal-IOP from baseline up to 6, 12, 18, 24 and 36 months post-operatively with IOP lowering medication
Time frame: up to 36 months
Assess mean medicated IOP
Mean medicated IOP at Baseline and 6, 12, 18, 24 and 36 months after surgery
Time frame: Up to 36 months
Mean number of IOP lowering pharmacological treatments
Mean number of IOP-lowering pharmacological treatments at baseline and 6, 12, 18, 24 and 36 months after surgery
Time frame: Up to 36 months
Mean change in post op IOP and IOP lowering pharmacological treatment
Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 6, 12, 18 and 36 months after surgery
Time frame: 6, 12, 18, and 36 months
Assess absolute success rate
Absolute success rate: proportion of med-free eyes with ≥ 20% decrease from baseline and below 18 mmHg at 6, 12, 18, 24 and 36 months after surgery
Time frame: Up to 36 months
Assess qualified success rate
Qualified success rate: proportion of eyes with ≥ 20% decrease from baseline and below 18 mmHg at 6, 12, 18, 24 and 36 months after surgery
Time frame: Up to 36 months
Rate of patients with a reduction in post operative IOP
Rate of patients with at least a 20%, 30%, 40% and more than 50% reduction in post operative IOP, with or without combined medical treatments, at each visit
Time frame: Up to 36 months
Proportion of eyes free of ocular hypotensive medications
Proportion of eyes free of ocular hypotensive medications at 6, 12, 18, 24 and 36 months after surgery
Time frame: Up to 36 months
Assess proportion of eyes with IOP between 6-18 mmHg
Proportion of eyes with IOP ≥6 mmHg and ≤ 18 mmHg, the same with med-free eyes only
Time frame: Up to 36 months
Proportion of eyes with IOP between 6-16 mmHg
Proportion of eyes with IOP ≥6 mmHg and ≤ 16 mmHg, the same with med-free eyes only
Time frame: Up to 36 months
Average number of adjunctive therapies post-operatively
Average number of adjunctive therapies (needling, goniopuncture, SLT, …) performed up to 36 months postoperatively
Time frame: Up to 36 months
Rate of patients with no filtering blebs
Rate of patients with no filtering bleb, average duration of filtering blebs
Time frame: Up to 36 months
Assess the surgical procedure
To evaluate the surgical procedure (duration of operation, ease of implantation)
Time frame: Day 0, day of surgery
Assess patient satisfaction post-operatively
To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity
Time frame: Up to 36 months
Describe patient's quality of life
To describe changes in quality of life (EQ5D)
Time frame: Up to 36 months
Assess rate of intraoperative and post-operative related adverse device effects
Rate of intraoperative and post-operative device related ocular adverse events and adverse device effect
Time frame: Up to 36 months
Review slit lamp, gonioscopy and fundus findings
Slit lamp, gonioscopy and fundus findings
Time frame: Up to 36 months
Determine rate of BCVA
Rate of best corrected visual acuity variation (BCVA)
Time frame: Up to 36 months
Assess rate of Visual field mean deviation variation (VF MD)
Rate of Visual field mean deviation variation (VF MD)
Time frame: Up to 36 months
Determine rate of C/D ratio mean deviation
Rate of C/D ratio mean deviation
Time frame: Up to 36 months
Assess rate of sight threatening events
Rate of sight threatening events
Time frame: Up to 36 months
Assess rate of change in endothelial cell density and central corneal thickness
Rate of change in endothelial cell density (ECD) and central corneal thickness (CCT)
Time frame: Up to 36 months
Assess rate of occurrence of SV22 movements in the supraciliary space
Rate of occurrence of SV22 movements inside the supraciliary space (SCS), defined as a change of position of the anterior edge of the implant of at least 200 µm measured on UBM from D7 to any timepoint
Time frame: Up to 36 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Feb 2025, 32 months.
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 32 months is close to 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.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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