Open Angle Glaucoma (OAG)CyCLENCT01097174
CyPass Clinical Experience Study
An observational study of Open Angle Glaucoma (OAG), run by Transcend Medical, Inc. at 14 sites in 6 countries.
Trial summary
This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open Angle Glaucoma (OAG)
- What is being tested?
- CyPass Micro-Stent
- Type of treatment
- Medical device
- How many people
- 555 participants
- Where
- 14 sitesin 6 countries
- Study dates
- Dec 2009to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Glaucoma
Who may be able to join
- Diagnosis of OAG
- IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)
Who cannot join
- Acute angle closure, narrow angle, uveitic or neovascular glaucoma
- Normal tension glaucoma
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Germany5 sites
Schlosspark-Klinik, Department of Ophthalmology
Berlin
Knappschaftskrankenhaus Bochum-Langendreer
Bochum
AugenKlinik Cham
Cham
Klinik fur Augenheilkunde, Campus Lubeck
Lübeck
Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum
Neubrandenburg
Spain5 sites
Institut Catala de Retina
Barcelona
Instituto de Microcirugia Ocular
Barcelona
Hospital Clinico San Carlos
Madrid
Ramón y Cajal University Hospital
Madrid
Hospital Universiatrio Miguel Servet
Zaragoza
Bulgaria1 site
Specialized Hospital for Active Treatment of Ophthalmologic Diseases
Sofia
Italy1 site
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio
Catania
About this study
Official title: A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience
This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.
- Conditions
- Open Angle Glaucoma (OAG)
- Being tested
- CyPass Micro-Stent
- Keywords
- Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyPass Micro-StentDevice
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of they eye.
| Study group | Role | What they receive |
|---|---|---|
| CyPass Micro-stent | Patients in whom CyPass Micro-stent implantation was attempted. Receives: Device: CyPass Micro-Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative and postoperative adverse events
Measured: Day 0 - Year 3
Secondary outcomes (2)
Intraocular pressure (IOP) reduction
Measured: 1 - 36 months postoperatively
Ocular hypotensive medication use
Measured: 1 - 36 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma (OAG)Studies 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
- Case only
- Time perspective
- Other
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transcend Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsontcho (Sean) Ianchulev, MD, MPH, Study director, Transcend Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097174
- Sponsor's protocol ID
- TMI-09-02
- Acronym
- CyCLE
- Status last verified
- Oct 2016
- First submitted
- 30 Mar 2010
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience
- ClinicalTrials.gov ID
- NCT01097174
- Acronym / sponsor ID
- CyCLE / TMI-09-02
- Conditions
- Open Angle Glaucoma (OAG)
- Keywords
- Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Transcend Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Apr 2010 (estimated)
- 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.
This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CyPass Micro-stent | – | Device: CyPass Micro-StentPatients in whom CyPass Micro-stent implantation was attempted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Glaucoma
Key inclusion criteria (2 listed)
- Diagnosis of OAG
- IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)
Key exclusion criteria (2 listed)
- Acute angle closure, narrow angle, uveitic or neovascular glaucoma
- Normal tension glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyPass Micro-StentThe CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of they eye. | Device | CyPass Micro-stent |
Primary outcome
Incidence of intraoperative and postoperative adverse events
Time frame: Day 0 - Year 3
2 secondary outcomes
Intraocular pressure (IOP) reduction
Time frame: 1 - 36 months postoperatively
Ocular hypotensive medication use
Time frame: 1 - 36 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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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.
Tsontcho (Sean) Ianchulev, MD, MPH study director
Transcend Medical, Inc.
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma (OAG), run by Transcend Medical, Inc. at 14 sites in 6 countries.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Spain, Austria, Bulgaria, Italy and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of intraoperative and postoperative adverse events (time frame: Day 0 - Year 3). 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 15 May 2017.