Open Angle GlaucomaNCT02784249
A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction
A study testing Goniotomy, Trabecular Micro-Bypass Stent and Cataract Extraction in people with Open Angle Glaucoma, run by New World Medical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Goniotomy, Trabecular Micro-Bypass Stent and Cataract Extraction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2018
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of open angle glaucoma (including pseudoexfoliation and pigmentary glaucoma)
- Diagnosis of mild to moderate glaucoma as defined by ICD-9 staging definitions 365.71 Mild/365.72 Moderate (including visual field defects and/or characteristic optic nerve abnormalities consistent with mild to moderate glaucoma)
- Planned removal of a visually significant cataract as determined by the Investigator (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction
Who cannot join
- Any glaucoma diagnosis other than those noted in inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Multi-Center, Open-Label Trial Comparing a Novel Goniotomy Procedure and an Ab Interno Trabecular Bypass Device in the Treatment of Mild to Moderate Glaucoma in Patients Undergoing Cataract Extraction
The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.
- Conditions
- Open Angle Glaucoma
- Being tested
- Goniotomy, Trabecular Micro-Bypass Stent, Cataract Extraction
- Keywords
- Glaucoma, glaucoma surgery, ab interno
- 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.
GoniotomyProcedure or surgery
Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.
Trabecular Micro-Bypass StentDevice
Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
Cataract ExtractionProcedure or surgery
Cataract extraction via Phaco and PCIOL implant.
| Study group | Role | What they receive |
|---|---|---|
| Goniotomy | Experimental | Procedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant. Receives: Procedure: Goniotomy; Procedure: Cataract Extraction |
| Trabecular Micro-Bypass Stent | Active comparator | Procedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant. Receives: Device: Trabecular Micro-Bypass Stent; Procedure: Cataract Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in mean IOP
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 posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017
- Study completionDec 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- New World Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luana Wilbur, BS, Study director, Pilot to Pivotal Consulting, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784249
- Sponsor's protocol ID
- C-16-04
- Status last verified
- Jul 2021
- First submitted
- 24 May 2016
- Last updated
- 14 Jul 2021
- 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 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center, Open-Label Trial Comparing a Novel Goniotomy Procedure and an Ab Interno Trabecular Bypass Device in the Treatment of Mild to Moderate Glaucoma in Patients Undergoing Cataract Extraction
- ClinicalTrials.gov ID
- NCT02784249
- Acronym / sponsor ID
- C-16-04
- Conditions
- Open Angle Glaucoma
- Keywords
- Glaucoma, glaucoma surgery, ab interno
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- New World Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 May 2016 (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.
The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goniotomy | Experimental | Procedure: Goniotomy, Procedure: Cataract ExtractionProcedure: Goniotomy and trabecular excision in combination with planned cataract extraction via Phaco and PCIOL implant. |
| Trabecular Micro-Bypass Stent | Active comparator | Device: Trabecular Micro-Bypass Stent, Procedure: Cataract ExtractionProcedure: Device implantation in combination with planned cataract extraction via Phaco and PCIOL implant. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of open angle glaucoma (including pseudoexfoliation and pigmentary glaucoma)
- Diagnosis of mild to moderate glaucoma as defined by ICD-9 staging definitions 365.71 Mild/365.72 Moderate (including visual field defects and/or characteristic optic nerve abnormalities consistent with mild to moderate glaucoma)
- Planned removal of a visually significant cataract as determined by the Investigator (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction
Key exclusion criteria (1 listed)
- Any glaucoma diagnosis other than those noted in inclusion criteria
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 |
|---|---|---|
| GoniotomyProcedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant. | Procedure or surgery | Goniotomy |
| Trabecular Micro-Bypass StentProcedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant. | Device | Trabecular Micro-Bypass Stent |
| Cataract ExtractionCataract extraction via Phaco and PCIOL implant. | Procedure or surgery | Goniotomy, Trabecular Micro-Bypass Stent |
Primary outcome
Percent reduction in mean IOP
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 14 Jul 2021.
- 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.
Luana Wilbur, BS study director
Pilot to Pivotal Consulting, 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 Goniotomy, Trabecular Micro-Bypass Stent and Cataract Extraction in people with Open Angle Glaucoma, run by New World Medical, Inc. at 1 site in United States.
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 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: finished, as of the sponsor's last update on 14 Jul 2021. 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 United States. 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?
Percent reduction in mean IOP (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 14 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.