Open-Angle GlaucomaNCT06953349
Efficacy of Surgical Systems in Combination With Phacoemulsification: a Retrospective Analysis
An observational study of Open-Angle Glaucoma, run by Barnet Dulaney Perkins Eye Centers at 1 site in United States.
Trial summary
Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma
- What is being tested?
- Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 31 Dec 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 300 subjects that have undergone CEIOL/OMNI/Hydrus
Who may be able to join
- Subjects with h/o CEIOL/OMNI/Hydrus (chosen based on subjects on more than 1 medication pre-operatively) with at least 3 years of follow up data
- have Glaucoma
Who cannot join
- Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.
- Patients with refractory CME or CME persisting 3 months or more post-operatively
- Patients with incomplete IOP, medication logs or VF data within post-operative period
- Prior incisional surgery or MIGS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206
Derek J Arnson, Master of Education, 4804201005, derek.arnson@researchavp.com
Christine Funke, Medical Doctor, 4804201005, christine.funke@BDPEC.com
About this study
Official title: Real-World Efficacy of Hydrus Microstent With OMNI Surgical System in Combination With Phacoemulsification: a Retrospective Analysis
Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis
Read the detailed description
The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma
- Conditions
- Open-Angle Glaucoma
- Being tested
- Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis
- Keywords
- Hydrus Microstent, OMNI Surgical System, Phacoemulsification
- 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.
Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysisProcedure or surgery
Also called OMNI, Hydrus Microstent
The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma
| Study group | Role | What they receive |
|---|---|---|
| Single Group/Cohort retrospectively utilized | This will be 300 eyes that have undergone the combination of Phacoemulsification, OMNI Canaloplasty and Hydrus microstent that will successfully lower IOP in ethnically-diverse patients with Open Angle Glaucoma Receives: Procedure: Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured Efficacy of Surgical Process with Phacoemulsification
Primary endpoint stratified by complete or qualified success:
- Proportion of patients with complete success (%) - without the use of medications
Measured: 24 months
Secondary outcomes (9)
Additional Benefits of the Surgical System and Phacoemulsification
- Proportion of patients with qualified success (%) - with glaucoma meds without increase from baseline
Measured: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
- Overall IOP reduction from baseline (mmHg)
Measured: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
- Overall medication reduction (#0-5)
Measured: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
- Rate of mean deviation change (dB)
Measured: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
- SSIs (% on trabeculectomy, glaucoma drainage implant (GDI), other)
Measured: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Additional Secondary Endpoint stratified by Complete or Qualified surgical success defined by the following:
- Complete success: Without the use of glaucoma medications
- Qualified success: Using glaucoma medications, but without an increase from the baseline number
Measured: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
- Overall medication reduction from baseline, measured at 12, 24 and 36 month timepoints
Measured: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
- Overall IOP reduction from baseline, measured at 12, 24 and 36 month timepoints
Measured: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
- Rate of mean deviation change from baseline to postop time points in Humphrey visual field tests
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start31 Mar 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnet Dulaney Perkins Eye Centers
- Sponsor type
- Research network
- Collaborators
- Alcon, a Novartis Company
- Responsible party
- Sponsor
- Investigators
- Christine Funke, Medical Doctor, Principal investigator, Barnet Dulaney Perkins Eye Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953349
- Sponsor's protocol ID
- Alcon - IIT Proposal 95537309
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To report on surgical success after cataract surgery in ethnically diverse (Caucasian, Asian, African American, Hispanic, Tribal) patients with multiple glaucoma using combined MIGS procedures.
Publications
Montesano G, Ometto G, Ahmed IIK, Ramulu PY, Chang DF, Crabb DP, Gazzard G. Five-Year Visual Field Outcomes of the HORIZON Trial. Am J Ophthalmol. 2023 Jul;251:143-155. doi: 10.1016/j.ajo.2023.02.008. Epub 2023 Feb 21.
PubMed 36813144Hirsch L, Cotliar J, Vold S, Selvadurai D, Campbell A, Ferreira G, Aminlari A, Cho A, Heersink S, Hochman M, Gallardo M, Williamson B, Phan R, Nelson C, Dickerson JE Jr. Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study. J Cataract Refract Surg. 2021 Jul 1;47(7):907-915. doi: 10.1097/j.jcrs.0000000000000552.
PubMed 33315733Sarkisian SR Jr, Radcliffe N, Harasymowycz P, Vold S, Patrianakos T, Zhang A, Herndon L, Brubaker J, Moster R, Francis B; ASCRS Glaucoma Clinical Committee. Visual outcomes of combined cataract surgery and minimally invasive glaucoma surgery. J Cataract Refract Surg. 2020 Oct;46(10):1422-1432. doi: 10.1097/j.jcrs.0000000000000317.
PubMed 32657904Laroche D, Desrosiers A, Ng C. Short-term report of early glaucoma surgery with a clear lens extraction and an intraocular lens, OMNI canaloplasty, and a HYDRUS microstent: a case series in younger patients. Front Ophthalmol (Lausanne). 2024 Jan 5;3:1288052. doi: 10.3389/fopht.2023.1288052. eCollection 2023.
PubMed 38983083Creagmile J, Kim WI, Scouarnec C. Hydrus Microstent implantation with OMNI Surgical System Ab interno canaloplasty for the management of open-angle glaucoma in phakic patients refractory to medical therapy. Am J Ophthalmol Case Rep. 2022 Nov 10;29:101749. doi: 10.1016/j.ajoc.2022.101749. eCollection 2023 Mar.
PubMed 36544749
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Efficacy of Hydrus Microstent With OMNI Surgical System in Combination With Phacoemulsification: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06953349
- Acronym / sponsor ID
- Alcon - IIT Proposal 95537309
- Conditions
- Open-Angle Glaucoma
- Keywords
- Hydrus Microstent, OMNI Surgical System, Phacoemulsification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Barnet Dulaney Perkins Eye CentersResearch network
- Collaborators
- Alcon, a Novartis Company
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 May 2025 (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.
Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis
Detailed description
The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group/Cohort retrospectively utilized | – | Procedure: Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysisThis will be 300 eyes that have undergone the combination of Phacoemulsification, OMNI Canaloplasty and Hydrus microstent that will successfully lower IOP in ethnically-diverse patients with Open Angle Glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 subjects that have undergone CEIOL/OMNI/Hydrus
Key inclusion criteria (2 listed)
- Subjects with h/o CEIOL/OMNI/Hydrus (chosen based on subjects on more than 1 medication pre-operatively) with at least 3 years of follow up data
- have Glaucoma
Key exclusion criteria (4 listed)
- Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.
- Patients with refractory CME or CME persisting 3 months or more post-operatively
- Patients with incomplete IOP, medication logs or VF data within post-operative period
- Prior incisional surgery or MIGS
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 |
|---|---|---|
| Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysisAlso: OMNI, Hydrus MicrostentThe use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma | Procedure or surgery | Single Group/Cohort retrospectively utilized |
Primary outcome
Measured Efficacy of Surgical Process with Phacoemulsification
Time frame: 24 months
Primary endpoint stratified by complete or qualified success: • Proportion of patients with complete success (%) - without the use of medications
9 secondary outcomes
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time frame: 36 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 1 May 2025.
- Background: PubMed 36813144Montesano G, Ometto G, Ahmed IIK, Ramulu PY, Chang DF, Crabb DP, Gazzard G. Five-Year Visual Field Outcomes of the HORIZON Trial. Am J Ophthalmol. 2023 Jul;251:143-155. doi: 10.1016/j.ajo.2023.02.008. Epub 2023 Feb 21.
- Background: PubMed 33315733Hirsch L, Cotliar J, Vold S, Selvadurai D, Campbell A, Ferreira G, Aminlari A, Cho A, Heersink S, Hochman M, Gallardo M, Williamson B, Phan R, Nelson C, Dickerson JE Jr. Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study. J Cataract Refract Surg. 2021 Jul 1;47(7):907-915. doi: 10.1097/j.jcrs.0000000000000552.
- Background: PubMed 32657904Sarkisian SR Jr, Radcliffe N, Harasymowycz P, Vold S, Patrianakos T, Zhang A, Herndon L, Brubaker J, Moster R, Francis B; ASCRS Glaucoma Clinical Committee. Visual outcomes of combined cataract surgery and minimally invasive glaucoma surgery. J Cataract Refract Surg. 2020 Oct;46(10):1422-1432. doi: 10.1097/j.jcrs.0000000000000317.
- Background: PubMed 38983083Laroche D, Desrosiers A, Ng C. Short-term report of early glaucoma surgery with a clear lens extraction and an intraocular lens, OMNI canaloplasty, and a HYDRUS microstent: a case series in younger patients. Front Ophthalmol (Lausanne). 2024 Jan 5;3:1288052. doi: 10.3389/fopht.2023.1288052. eCollection 2023.
- Background: PubMed 36544749Creagmile J, Kim WI, Scouarnec C. Hydrus Microstent implantation with OMNI Surgical System Ab interno canaloplasty for the management of open-angle glaucoma in phakic patients refractory to medical therapy. Am J Ophthalmol Case Rep. 2022 Nov 10;29:101749. doi: 10.1016/j.ajoc.2022.101749. eCollection 2023 Mar.
- Individual participant dataSharing planned: Yes. To report on surgical success after cataract surgery in ethnically diverse (Caucasian, Asian, African American, Hispanic, Tribal) patients with multiple glaucoma using combined MIGS procedures.
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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.
Christine Funke, Medical Doctor principal investigator
Barnet Dulaney Perkins Eye Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open-Angle Glaucoma, run by Barnet Dulaney Perkins Eye Centers 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 2 inclusion and 4 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 1 May 2025. 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?
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 Derek J Arnson, Master of Education (4804201005, derek.arnson@researchavp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured Efficacy of Surgical Process with Phacoemulsification (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953349, which also lists 5 linked publications.
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 1 May 2025.