Open Angle GlaucomaNCT06230393
An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
An observational study of Open Angle Glaucoma and Intraocular Pressure, run by New World Medical, Inc. at 1 site in Costa Rica.
Trial summary
The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open Angle Glaucoma, Intraocular Pressure
- What is being tested?
- STREAMLINE® SURGICAL SYSTEM
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteCosta Rica
- Study dates
- 1 Jun 2024to 4 Dec 2025
- 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
- Child, Adult, Older adult
Study population: Subjects who participated in the DF6-CL-20-01 trial
Who may be able to join
- participated in the DF6-CL-20-01 trial.
Who cannot join
- lost to follow up in the DF6-CL-20-01 trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Extension Trial to Evaluate the Long Term Safety and Effectiveness of the STREAMLINE® SURGICAL SYSTEM in Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM
Read the detailed description
A Retrospective, nonrandomized, open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE® SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol.
- Conditions
- Open Angle Glaucoma, Intraocular Pressure
- Being tested
- STREAMLINE® SURGICAL SYSTEM
- Keywords
- Intraocular Pressure, Glaucoma, MIGS
- 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.
STREAMLINE® SURGICAL SYSTEMDevice
STREAMLINE® SURGICAL SYSTEM
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IOP
From Screening to annual endpoints
Measured: 24months; 36 months; 48months, 60 months
Secondary outcomes (1)
Number of IOP lowering medications
Compared to screening in DF6-CL-20-01 trial
Measured: 24months; 36 months; 48months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jun 2024
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Why it stopped: Sponsor decision to close this extension study due to reduction in sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies 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
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- New World Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230393
- Sponsor's protocol ID
- DF6-CL-24-02
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Trial to Evaluate the Long Term Safety and Effectiveness of the STREAMLINE® SURGICAL SYSTEM in Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
- ClinicalTrials.gov ID
- NCT06230393
- Acronym / sponsor ID
- DF6-CL-24-02
- Conditions
- Open Angle Glaucoma, Intraocular Pressure
- Keywords
- Intraocular Pressure, Glaucoma, MIGS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision to close this extension study due to reduction in sample size.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- New World Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 30 Jan 2024 (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 evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM
Detailed description
A Retrospective, nonrandomized, open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE® SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who participated in the DF6-CL-20-01 trial
Key inclusion criteria (1 listed)
- participated in the DF6-CL-20-01 trial.
Key exclusion criteria (1 listed)
- lost to follow up in the DF6-CL-20-01 trial
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 |
|---|---|---|
| STREAMLINE® SURGICAL SYSTEMSTREAMLINE® SURGICAL SYSTEM | Device | – |
Primary outcome
Change in IOP
Time frame: 24months; 36 months; 48months, 60 months
From Screening to annual endpoints
1 secondary outcome
Number of IOP lowering medications
Time frame: 24months; 36 months; 48months, 60 months
Results and safety
The study was stopped early (reason given: Sponsor decision to close this extension study due to reduction in sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- 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 and Intraocular Pressure, run by New World Medical, Inc. at 1 site in Costa Rica.
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: stopped early, as of the sponsor's last update on 30 Mar 2026. 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 Costa Rica. 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 was stopped early (reason given: Sponsor decision to close this extension study due to reduction in sample size.). 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?
Change in IOP (time frame: 24months; 36 months; 48months, 60 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 30 Mar 2026.