Glaucoma, Open-AngleNCT05949242
Clinical Outcomes in Cataract Surgery With OMNI Canaloplasty vs Cataract Surgery With OMNI Canaloplasty and Hydrus Stent
A study testing OMNI canaloplasty and Hydrus microstent in people with Glaucoma, Open-Angle, run by Ridge Eye Care at 4 sites in United States.
Trial summary
The goal of this clinical trial is to look at the difference in pressure lowering effects in patients having two different combinations of minimally invasive glaucoma surgery (MIGS) at the time of their cataract surgery. Eligible patients will have mild to moderate glaucoma and be candidates for cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- OMNI canaloplasty and Hydrus microstent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Apr 2023to Oct 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with bilateral mild to moderate open angle glaucoma:
- Including pseudoexfoliation (PXE) and pigment dispersion (PDS) According to ICD-10 guidelines and with visual field (VF) mean deviation -12 decibels (dB) or better With visually significant age-related cataract undergoing uncomplicated cataract surgery Able to randomize first eye to either treatment group, contralateral eye to receive other treatment Fairly symmetric glaucoma with cup to disc (C/D) asymmetry ≤ 0.1 and similar OCT RNFL and VF mean deviation IOP ≥ 20 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s); ≤3mmHg between the eyes Central corneal thickness (CCT) 480 to 620µm No prior ocular surgery including corneal refractive surgery; No selective laser trabeculoplasty (SLT) within 3 months of baseline visit, no history of intracameral implants Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively
Who cannot join
- Subjects with secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma) Uncontrolled intraocular pressure on maximum tolerated medical therapy; unable to wash-out intraocular pressure (IOP) lowering drops Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities leading to poor angle visualization H/o corneal disease or dystrophy Pathological myopia with degeneration that affects diagnostic imaging Clinically significant ocular pathology or degenerative diseases that affect vision, humphrey visual field (HVF), or OCT Inability to perform reliable HVF /OCT
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Royo Eye Care
Marysville, California, 95901
Table Mountain Eye Care
Oroville, California, 95966
Ridge Eye Institute
Paradise, California, 95969
Feather River Eye Care
Yuba City, California, 95991
About this study
Official title: Comparison of Clinical Outcomes in Patients Undergoing Cataract Surgery With OMNI Canaloplasty vs Cataract Surgery With OMNI Canaloplasty and Hydrus Stent
The goal of this clinical trial is to look at the difference in pressure lowering effects in patients having two different combinations of minimally invasive glaucoma surgery (MIGS) at the time of their cataract surgery. Eligible patients will have mild to moderate glaucoma and be candidates for cataract surgery. The trial will look at the eye pressure before and one year after cataract surgery in patients. One eye in each patient will have cataract surgery with canaloplasty using OMNI. The patients other eye will have cataract surgery with canaloplasty and a HYDRUS stent. The trial will look at the differences in eye pressure and if patients are able to need fewer eye pressure lowering drops after surgery.
Study participants will undergo preop testing of pressure, vision, slit lamp exam, ocular coherence tomography (OCT) of the nerve fiber layer (NFL) analysis, and visual field prior to cataract surgery with MIGS. One day, one week, one month, 6 month, and 1 year exams will be performed to check pressure, vision, slit lamp exam, and number of necessary eye pressure medications in each eye.
Read the detailed description
The purpose of this research study is to:
- Determine the differing pressure lowering effects between OMNI canaloplasty alone versus when combined with HYDRUS microstent. Both surgical study devices are widely used by themselves in conjunction with cataract surgery. While many surgeons have begun combining the two procedures, this will be one of the first studies to randomize (assign by chance) one eye to OMNI canaloplasty alone and the other eye to OMNI canaloplasty with HYDRUS stent and report the results after one year.
About 80 subjects aged 18 years and older will participate in this study.
WHAT WILL HAPPEN DURING THE STUDY?
Your participation in this study will last approximately one year and will include approximately seven study visits to the study center and two visits to the surgery center.
Screening:
Before any study-related tests and procedures are performed, you will be asked to read and sign this consent document. The following screening tests and procedures will then be performed to determine if you qualify to take part in this study:
- Visual field
- OCT analysis of the nerve and cornea - your nerve and cornea will be measured using optical coherence tomography (OCT) equipment. This is painless, non-invasive (it does not involve puncturing or cutting) and is similar to having photographs taken of your eye. You will be required to sit still during the brief scanning procedure (a few seconds)
- Slit lamp exam with gonioscopy - a close inspection of the front of the eye using a machine that magnifies the eye and provides a beam of light to light the structures of the eye
- Eye pressure test - measurement of the pressure inside the eye. The pressure in your eyes will be measured using an instrument known as a tonometer
- Visual acuity test - a test involving reading letters off a chart to determine how well you can see
This study will use competitive enrollment. This means that when a target number of subjects begins the study, all further enrollment will be closed. Therefore, it is possible that you could be
in the screening phase, ready to begin the study, and be discontinued without your consent if the target number of subjects has already begun the study.
If you qualify to take part in this study and go on to receive the study treatment, then the following will happen:
Washout Period: You will be asked to stop taking your eye drops to treat your glaucoma. This is called a washout period, during which the effects of these medications leave your body.
Study Treatment: You will be randomly assigned by chance (like the flip of a coin) to receive either OMNI canaloplasty or OMNI canaloplasty with HYDRUS microstent. You will have a 50% (1 in 2) chance of receiving OMNI canaloplasty alone or OMNI canaloplasty with HYDRUS microstent. This is a not a blinded study, which means that you, the study doctor, study staff and the sponsor will know the study treatment you are given.
You will have the following study visits and undergo the following procedures:
- Preoperative and postoperative care will be the same as a standard cataract surgery consisting of one day, one week, one month, six month and one year follow-up exams. The only difference for study subjects is they will be asked to stop all glaucoma drops one month prior to their pre-op exam and one year post-op exam.
After Study Treatment:
Glaucoma is a permanent and irreversible condition that requires lifelong monitoring with an eye care professional. Sometimes additional treatment is required. Your eye specialist will recommend follow-up care based on your personal findings.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- OMNI canaloplasty, Hydrus microstent
- 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 canaloplastyDevice
OMNI device is used to catheterize Schlemm's canal for 180 degrees and perform canaloplasty. Viscoelastic is eluded upon retraction of the catheter performing viscodilation of the canal
Hydrus microstentDevice
Hydrus stent is introduced into Schlemm's canal to scaffold open the canal
| Study group | Role | What they receive |
|---|---|---|
| OMNI canaloplasty with cataract surgery | Active comparator | participant will undergo OMNI canaloplasty with cataract surgery in one randomized eye Receives: Device: OMNI canaloplasty |
| OMNI canaloplasty and Hydrus with cataract surgery | Active comparator | participant will undergo OMNI canaloplasty and Hydrus with cataract surgery in the contralateral eye Receives: Device: OMNI canaloplasty; Device: Hydrus microstent |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in unmedicated intraocular pressure from baseline at 12 months
check intraocular pressure at start date and at 12 months after washout of all pressure controlling drops
Measured: 12 months
Secondary outcomes (2)
reduction in number of medications needed to control intraocular pressure from baseline
compare number of drops prior to intervention with number of drops needed to control intraocular pressure at 12 months
Measured: 12 months
percentage of patients with greater than 20% reduction in intraocular pressure from baseline
examine percentage of patients with a 20% reduction from their baseline unmedicated intraocular pressure at 12 months
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 posted17 Jul 2023
- Study start7 Apr 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Model description
- Participants will have one eye randomized to each arm of the trial: one eye will receive OMNI canaloplasty alone the other eye will receive OMNI canaloplasty and Hydrus microstent
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ridge Eye Care
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Douglas McGraw, D.O., Ridge Eye Care
- Investigators
- Douglas McGraw, DO, Principal investigator, Ridge Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949242
- Sponsor's protocol ID
- 76998263
- Status last verified
- Apr 2025
- First submitted
- 10 Jul 2023
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes in Patients Undergoing Cataract Surgery With OMNI Canaloplasty vs Cataract Surgery With OMNI Canaloplasty and Hydrus Stent
- ClinicalTrials.gov ID
- NCT05949242
- Acronym / sponsor ID
- 76998263
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ridge Eye CareUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 Jul 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.
The goal of this clinical trial is to look at the difference in pressure lowering effects in patients having two different combinations of minimally invasive glaucoma surgery (MIGS) at the time of their cataract surgery. Eligible patients will have mild to moderate glaucoma and be candidates for cataract surgery. The trial will look at the eye pressure before and one year after cataract surgery in patients. One eye in each patient will have cataract surgery with canaloplasty using OMNI. The patients other eye will have cataract surgery with canaloplasty and a HYDRUS stent. The trial will look at the differences in eye pressure and if patients are able to need fewer eye pressure lowering drops after surgery.
Study participants will undergo preop testing of pressure, vision, slit lamp exam, ocular coherence tomography (OCT) of the nerve fiber layer (NFL) analysis, and visual field prior to cataract surgery with MIGS. One day, one week, one month, 6 month, and 1 year exams will be performed to check pressure, vision, slit lamp exam, and number of necessary eye pressure medications in each eye.
Detailed description
The purpose of this research study is to:
- Determine the differing pressure lowering effects between OMNI canaloplasty alone versus when combined with HYDRUS microstent. Both surgical study devices are widely used by themselves in conjunction with cataract surgery. While many surgeons have begun combining the two procedures, this will be one of the first studies to randomize (assign by chance) one eye to OMNI canaloplasty alone and the other eye to OMNI canaloplasty with HYDRUS stent and report the results after one year.
About 80 subjects aged 18 years and older will participate in this study.
WHAT WILL HAPPEN DURING THE STUDY?
Your participation in this study will last approximately one year and will include approximately seven study visits to the study center and two visits to the surgery center.
Screening:
Before any study-related tests and procedures are performed, you will be asked to read and sign this consent document. The following screening tests and procedures will then be performed to determine if you qualify to take part in this study:
- Visual field
- OCT analysis of the nerve and cornea - your nerve and cornea will be measured using optical coherence tomography (OCT) equipment. This is painless, non-invasive (it does not involve puncturing or cutting) and is similar to having photographs taken of your eye. You will be required to sit still during the brief scanning procedure (a few seconds)
- Slit lamp exam with gonioscopy - a close inspection of the front of the eye using a machine that magnifies the eye and provides a beam of light to light the structures of the eye
- Eye pressure test - measurement of the pressure inside the eye. The pressure in your eyes will be measured using an instrument known as a tonometer
- Visual acuity test - a test involving reading letters off a chart to determine how well you can see
This study will use competitive enrollment. This means that when a target number of subjects begins the study, all further enrollment will be closed. Therefore, it is possible that you could be
in the screening phase, ready to begin the study, and be discontinued without your consent if the target number of subjects has already begun the study.
If you qualify to take part in this study and go on to receive the study treatment, then the following will happen:
Washout Period: You will be asked to stop taking your eye drops to treat your glaucoma. This is called a washout period, during which the effects of these medications leave your body.
Study Treatment: You will be randomly assigned by chance (like the flip of a coin) to receive either OMNI canaloplasty or OMNI canaloplasty with HYDRUS microstent. You will have a 50% (1 in 2) chance of receiving OMNI canaloplasty alone or OMNI canaloplasty with HYDRUS microstent. This is a not a blinded study, which means that you, the study doctor, study staff and the sponsor will know the study treatment you are given.
You will have the following study visits and undergo the following procedures:
- Preoperative and postoperative care will be the same as a standard cataract surgery consisting of one day, one week, one month, six month and one year follow-up exams. The only difference for study subjects is they will be asked to stop all glaucoma drops one month prior to their pre-op exam and one year post-op exam.
After Study Treatment:
Glaucoma is a permanent and irreversible condition that requires lifelong monitoring with an eye care professional. Sometimes additional treatment is required. Your eye specialist will recommend follow-up care based on your personal findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will have one eye randomized to each arm of the trial: one eye will receive OMNI canaloplasty alone the other eye will receive OMNI canaloplasty and Hydrus microstent
| Arm | Type | Receives |
|---|---|---|
| OMNI canaloplasty with cataract surgery | Active comparator | Device: OMNI canaloplastyparticipant will undergo OMNI canaloplasty with cataract surgery in one randomized eye |
| OMNI canaloplasty and Hydrus with cataract surgery | Active comparator | Device: OMNI canaloplasty, Device: Hydrus microstentparticipant will undergo OMNI canaloplasty and Hydrus with cataract surgery in the contralateral eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with bilateral mild to moderate open angle glaucoma:
- Including pseudoexfoliation (PXE) and pigment dispersion (PDS) According to ICD-10 guidelines and with visual field (VF) mean deviation -12 decibels (dB) or better With visually significant age-related cataract undergoing uncomplicated cataract surgery Able to randomize first eye to either treatment group, contralateral eye to receive other treatment Fairly symmetric glaucoma with cup to disc (C/D) asymmetry ≤ 0.1 and similar OCT RNFL and VF mean deviation IOP ≥ 20 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s); ≤3mmHg between the eyes Central corneal thickness (CCT) 480 to 620µm No prior ocular surgery including corneal refractive surgery; No selective laser trabeculoplasty (SLT) within 3 months of baseline visit, no history of intracameral implants Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively
Key exclusion criteria (1 listed)
- Subjects with secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma) Uncontrolled intraocular pressure on maximum tolerated medical therapy; unable to wash-out intraocular pressure (IOP) lowering drops Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities leading to poor angle visualization H/o corneal disease or dystrophy Pathological myopia with degeneration that affects diagnostic imaging Clinically significant ocular pathology or degenerative diseases that affect vision, humphrey visual field (HVF), or OCT Inability to perform reliable HVF /OCT
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 canaloplastyOMNI device is used to catheterize Schlemm's canal for 180 degrees and perform canaloplasty. Viscoelastic is eluded upon retraction of the catheter performing viscodilation of the canal | Device | OMNI canaloplasty and Hydrus with cataract surgery, OMNI canaloplasty with cataract surgery |
| Hydrus microstentHydrus stent is introduced into Schlemm's canal to scaffold open the canal | Device | OMNI canaloplasty and Hydrus with cataract surgery |
Primary outcome
change in unmedicated intraocular pressure from baseline at 12 months
Time frame: 12 months
check intraocular pressure at start date and at 12 months after washout of all pressure controlling drops
2 secondary outcomes
reduction in number of medications needed to control intraocular pressure from baseline
Time frame: 12 months
percentage of patients with greater than 20% reduction in intraocular pressure from baseline
Time frame: 12 months
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 6 Apr 2025.
- 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.
Douglas McGraw, DO principal investigator
Ridge Eye Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNI canaloplasty and Hydrus microstent in people with Glaucoma, Open-Angle, run by Ridge Eye Care at 4 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
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 unmedicated intraocular pressure from baseline at 12 months (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 6 Apr 2025.