Glaucoma, Open-AngleSAFARI FUNCT05159817
Study of an Interposition Supraciliary Implant in Patients With Open Angle Glaucoma
An observational study of Glaucoma, Open-Angle, run by Ciliatech at 1 site in Armenia.
Trial summary
The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- How many people
- 19 participants
- Where
- 1 siteArmenia
- Study dates
- 15 Dec 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655
Who may be able to join
- All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655
Who cannot join
- if cannot assist to all future follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentre, Observational Clinical Study Evaluating the Efficacy and Safety of a Novel Interposition Supraciliary Implant in Glaucoma Surgery
The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.
Read the detailed description
19 patients with primary open angle glaucoma (POAG) refractory to topical medical therapy were operated in late 2020 and a novel interposition supraciliary device implanted.
These patients reached 6 months follow-up and the original study had to be interrupted.
This observational study prolonges follow-up to 36 months
- Conditions
- Glaucoma, Open-Angle
- Medical subject headings
- Glaucoma, Open-Angle
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess post-op IOP reduction
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Measured: 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start15 Dec 2021
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciliatech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159817
- Sponsor's protocol ID
- SAFARI FU
- Acronym
- SAFARI FU
- Status last verified
- Feb 2023
- First submitted
- 3 Dec 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentre, Observational Clinical Study Evaluating the Efficacy and Safety of a Novel Interposition Supraciliary Implant in Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT05159817
- Acronym / sponsor ID
- SAFARI FU / SAFARI FU
- Conditions
- Glaucoma, Open-Angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- CiliatechIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.
Detailed description
19 patients with primary open angle glaucoma (POAG) refractory to topical medical therapy were operated in late 2020 and a novel interposition supraciliary device implanted.
These patients reached 6 months follow-up and the original study had to be interrupted.
This observational study prolonges follow-up to 36 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655
Key inclusion criteria (1 listed)
- All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655
Key exclusion criteria (1 listed)
- if cannot assist to all future follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess post-op IOP reduction
Time frame: 12, 24 and 36 months
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle, run by Ciliatech at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess post-op IOP reduction (time frame: 12, 24 and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.