GlaucomaNCT05131087
A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma
A study testing Cadence implant in people with Glaucoma, run by New World Medical, Inc. at 1 site in Mexico.
Trial summary
To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Cadence implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 8 Oct 2020to 5 Jul 2023
- Phase
- Interventional
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22-80 years of age.
- moderate to severe refractory glaucoma
- Able to consent
Who cannot join
- Women of child-bearing potential
- Intraocular surgery or laser within the last 3 months
- Ocular infection or inflammation within the last 6 months or currently active
- Current use of anti-coagulant therapy
- History of bleeding disorder or coagulopathies
- Subject plans to undergo any ocular surgery (including cataract surgery) during the study period
Show all 18Show fewer
- History of corneal transplantation
- History of ICE Syndrome or epithelial ingrowth/downgrowth
- History of congenital glaucoma
- Elevated episcleral venous pressure
- -. Persistent angle closure-
- Previous glaucoma filtration surgery- -Presence of conjunctival scarring -
- neovascular glaucoma
- AC lens or scleral sutured IOL
- Aphakia
- inability to DC contact lenses
- Presence of intraocular silicone oil
- Vitreous in AC
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.
Read the detailed description
CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach
- Conditions
- Glaucoma
- Being tested
- Cadence implant
- Keywords
- glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadence implantDevice
CADENCE Glaucoma Drainage Device System is a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach
| Study group | Role | What they receive |
|---|---|---|
| Cadence | Experimental | Cadence procedure Receives: Device: Cadence implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of AEs
comparison of intra-operative and post-operative adverse events observed to events reported in published literature,
Measured: 12 months
Secondary outcomes (3)
Surgical Experience Evaluation
An evaluation of the surgical experience using feedback questionnaire to describe specific note of performance characteristics of each implant.
Measured: 12 months
Change in IOP
Change in IOP from Screening to M12
Measured: 12 months
Change in IOP Lowering Medications
Change in IOP lowering medications from Screening to M12
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start8 Oct 2020
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- New World Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Sun, PhD, Study director, New World Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131087
- Sponsor's protocol ID
- DF8-CL-20-02
- Status last verified
- Jan 2023
- First submitted
- 2 Nov 2021
- Last updated
- 13 Oct 2023
- 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT05131087
- Acronym / sponsor ID
- DF8-CL-20-02
- Conditions
- Glaucoma
- Keywords
- glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- New World Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 23 Nov 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.
To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.
Detailed description
CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| Cadence | Experimental | Device: Cadence implantCadence procedure |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 22-80 years of age.
- moderate to severe refractory glaucoma
- Able to consent
Key exclusion criteria (18 listed)
- Women of child-bearing potential
- Intraocular surgery or laser within the last 3 months
- Ocular infection or inflammation within the last 6 months or currently active
- Current use of anti-coagulant therapy
- History of bleeding disorder or coagulopathies
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 |
|---|---|---|
| Cadence implantCADENCE Glaucoma Drainage Device System is a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach | Device | Cadence |
Primary outcome
Assessment of AEs
Time frame: 12 months
comparison of intra-operative and post-operative adverse events observed to events reported in published literature,
3 secondary outcomes
Surgical Experience Evaluation
Time frame: 12 months
Change in IOP
Time frame: 12 months
Change in IOP Lowering Medications
Time frame: 12 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 13 Oct 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.
Mark Sun, PhD study director
New World Medical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cadence implant in people with Glaucoma, run by New World Medical, Inc. at 1 site in Mexico.
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 3 inclusion and 18 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 13 Oct 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 Mexico. 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?
Assessment of AEs (time frame: 12 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 Oct 2023.