OAG - Open-Angle GlaucomaNCT05696561
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
A study testing Canaloplasty Device in people with OAG - Open-Angle Glaucoma, run by New World Medical, Inc. at 3 sites in 3 countries.
Trial summary
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- OAG - Open-Angle Glaucoma
- What is being tested?
- Canaloplasty Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Sep 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects qualifying for cataract surgery
- Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.
Who cannot join
- 1. Patients who cannot be washed-out of IOP-lowering medications.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Chile1 site, 1 recruiting
- Recruiting
Centro de la Vision
Santiago
Edison Villagran
Costa Rica1 site, 1 recruiting
- Recruiting
Clínica 20/20
San José
Nadja Dodero, +506 8375-8263
Claudio Orlich, MD
Honduras1 site, 1 recruiting
- Not yet recruiting
Centro Oftalmologico Robles
Santa Rosa de Copán
Gricelda Ortiz
About this study
Official title: A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma
- Conditions
- OAG - Open-Angle Glaucoma
- Being tested
- Canaloplasty Device
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canaloplasty DeviceDevice
Canaloplasty
| Study group | Role | What they receive |
|---|---|---|
| Treatment with a Canaloplasty Device | Other | US. FDA Approved Canaloplasty Device Receives: Device: Canaloplasty Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP change
Reduction in unmedicated IOP
Measured: Month12
Secondary outcomes (2)
IOP
Percentage Change in unmedicated IOP
Measured: Month12
IOP meds
Change in number of IOP lowering medications
Measured: Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start9 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OAG - 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New World Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mini Balaram, MD, Study director, New World Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696561
- Sponsor's protocol ID
- DF12-CL-22-01
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2023
- Last updated
- 27 Feb 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT05696561
- Acronym / sponsor ID
- DF12-CL-22-01
- Conditions
- OAG - Open-Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- New World Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Jan 2023 (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.
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with a Canaloplasty Device | Other | Device: Canaloplasty DeviceUS. FDA Approved Canaloplasty Device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects qualifying for cataract surgery
- Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.
Key exclusion criteria (1 listed)
- 1. Patients who cannot be washed-out of IOP-lowering medications.
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 |
|---|---|---|
| Canaloplasty DeviceCanaloplasty | Device | Treatment with a Canaloplasty Device |
Primary outcome
IOP change
Time frame: Month12
Reduction in unmedicated IOP
2 secondary outcomes
IOP
Time frame: Month12
IOP meds
Time frame: Month12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for OAG - Open-Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
Mini Balaram, MD study director
New World Medical, Inc.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canaloplasty Device in people with OAG - Open-Angle Glaucoma, run by New World Medical, Inc. at 3 sites in 3 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 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile, Costa Rica, Honduras. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Swetha Mandava, MS (9732049467, smandava@newworldmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP change (time frame: Month12). 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 27 Feb 2026.