Open Angle Glaucoma (OAG)RePASSNCT02228577
Safety and Performance Study of the CyPass System Applier Model 241
An observational study of Open Angle Glaucoma (OAG), run by Transcend Medical, Inc. at 1 site in Germany.
Trial summary
This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Open Angle Glaucoma (OAG)
- How many people
- 172 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Oct 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with OAG who underwent combination cataract/glaucoma surgery and received the CyPass Micro-Stent using the CyPass Applier Model 241
Who may be able to join
- Diagnosis of OAG
- CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation
Who cannot join
- Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Prior incisional glaucoma surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum
Neubrandenburg
About this study
Official title: A Study Assessing the Safety and Performance of the Transcend CyPass System Applier Model 241 for Implantation of the CyPass Micro-Stent in Subjects With Open Angle Glaucoma Who Underwent Cataract Surgery
This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.
- Conditions
- Open Angle Glaucoma (OAG)
- Medical subject headings
- Glaucoma, Open-Angle
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular adverse events in the study eye
Measured: Intraoperatively though the first 3 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
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
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transcend Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228577
- Sponsor's protocol ID
- TMI-14-01
- Acronym
- RePASS
- Status last verified
- Oct 2016
- First submitted
- 27 Aug 2014
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the Safety and Performance of the Transcend CyPass System Applier Model 241 for Implantation of the CyPass Micro-Stent in Subjects With Open Angle Glaucoma Who Underwent Cataract Surgery
- ClinicalTrials.gov ID
- NCT02228577
- Acronym / sponsor ID
- RePASS / TMI-14-01
- Conditions
- Open Angle Glaucoma (OAG)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Transcend Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Aug 2014 (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 is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with OAG who underwent combination cataract/glaucoma surgery and received the CyPass Micro-Stent using the CyPass Applier Model 241
Key inclusion criteria (2 listed)
- Diagnosis of OAG
- CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation
Key exclusion criteria (2 listed)
- Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Prior incisional glaucoma surgery
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
Ocular adverse events in the study eye
Time frame: Intraoperatively though the first 3 postoperative months
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 Nov 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 Open Angle Glaucoma (OAG), run by Transcend Medical, Inc. at 1 site in Germany.
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 Nov 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 Germany. 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?
Ocular adverse events in the study eye (time frame: Intraoperatively though the first 3 postoperative 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 15 Nov 2023.