Open Angle GlaucomaNCT04530084
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
A study testing OMNI Surgical System in people with Open Angle Glaucoma, run by Mark Gallardo, MD at 1 site in United States.
Trial summary
The overall objective of this study is to determine the safety and usability of OMNI surgical system in performing canaloplasty and trabeculotomy. Outcome measures will include 1) adverse events (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- OMNI Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 22 years or older.
- Visually significant cataract or pseudophakic with a posterior chamber intraocular lens (PCIOL)
- Diagnosed with open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma)
- Scheduled for canaloplasty and trabeculotomy
Who cannot join
- Any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract.
- Prior trabeculectomy, other bleb-forming glaucoma surgery (e.g. tube shunt), or implanted trabecular bypass stents.
- Any other ocular pathologies that may interfere with the study procedure or be exacerbated by the OMNI procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
El Paso Eye Surgeons
El Paso, Texas, 79902
About this study
The overall objective of this study is to determine the safety and usability of OMNI surgical system in performing canaloplasty and trabeculotomy. Outcome measures will include 1) adverse events (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive medications
- Conditions
- Open Angle Glaucoma
- Being tested
- OMNI Surgical System
- 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.
OMNI Surgical SystemDevice
Scheduled for canaloplasty and trabeculotomy with or without cataract extraction
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with open angle glaucoma | Experimental | Not described Receives: Device: OMNI Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (intraoperative and perioperative)
Measured: 3 months
Best Corrected Visual Acuity (BCVA)
Measured: 3 months
Secondary outcomes (2)
Mean intraocular pressure (IOP)
Measured: 3 months
Mean number of ocular hypotensive medications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start21 Aug 2020
- Primary completion22 Aug 2021 (estimated)
- Study completionDec 2021 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Gallardo, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Gallardo, MD, El Paso Eye Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530084
- Sponsor's protocol ID
- 1290569
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- 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 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
- ClinicalTrials.gov ID
- NCT04530084
- Acronym / sponsor ID
- 1290569
- Conditions
- Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mark Gallardo, MDUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 22 Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Aug 2020 (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 overall objective of this study is to determine the safety and usability of OMNI surgical system in performing canaloplasty and trabeculotomy. Outcome measures will include 1) adverse events (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive medications
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with open angle glaucoma | Experimental | Device: OMNI Surgical System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, 22 years or older.
- Visually significant cataract or pseudophakic with a posterior chamber intraocular lens (PCIOL)
- Diagnosed with open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma)
- Scheduled for canaloplasty and trabeculotomy
Key exclusion criteria (3 listed)
- Any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract.
- Prior trabeculectomy, other bleb-forming glaucoma surgery (e.g. tube shunt), or implanted trabecular bypass stents.
- Any other ocular pathologies that may interfere with the study procedure or be exacerbated by the OMNI procedure.
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 |
|---|---|---|
| OMNI Surgical SystemScheduled for canaloplasty and trabeculotomy with or without cataract extraction | Device | Diagnosed with open angle glaucoma |
Primary outcome
Adverse events (intraoperative and perioperative)
Time frame: 3 months
Best Corrected Visual Acuity (BCVA)
Time frame: 3 months
2 secondary outcomes
Mean intraocular pressure (IOP)
Time frame: 3 months
Mean number of ocular hypotensive medications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNI Surgical System in people with Open Angle Glaucoma, run by Mark Gallardo, MD 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Gallardo, MD ((915) 542-0279, gallardomark@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (intraoperative and perioperative) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 28 Aug 2020.