Open Angle GlaucomaNCT04503356
OMNI in Open-angle Glaucoma Treatment
A study testing OMNI as a standalone procedure and OMNI combined with cataract surgery in people with Open Angle Glaucoma and Cataract, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Cataract, Eye Diseases
- What is being tested?
- OMNI as a standalone procedure and OMNI combined with cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 sitePoland
- Study dates
- 17 Apr 2018to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma
- 0-3 topical ocular hypotensive medications at preoperative baseline. Fixed combinations counted as number of components
- Open angles (Shaffer grade ≥3)
- early or moderate glaucoma (based on visual field)
- Subjects with a combined procedure should have had uncomplicated cataract surgery (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence of zonular dehiscence or rupture, well centered IOL)
Who cannot join
- Any of the following prior treatments for glaucoma:
- Suprachoroidal stent
- Laser trabeculoplasty ≤6 months prior to OMNI procedure
- Trabecular bypass implanted ≤6 months prior to OMNI procedure
- Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve
- Prior canaloplasty, goniotomy, or trabeculotomy
Show all 9Show fewer
- Forms of glaucoma other than OAG including: acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Under treatment with oral carbonic anhydrase inhibitor at the preoperative visit
- Clinically significant ocular pathology, other than age-related cataract and glaucoma. (e.g. wet AMD, uveitis, corneal edema, proliferative diabetic retinopathy, optic neuritis in medical history)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Orlowski Hospital, Centre of Postgraduate Medical Education
Warsaw, 00-401
About this study
Official title: Evaluation of the Effectiveness of the New Surgical Method OMNI in the Treatment of Adult Patients With Open-angle Glaucoma
This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures.
Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.
- Conditions
- Open Angle Glaucoma, Cataract, Eye Diseases, Glaucoma
- Being tested
- OMNI as a standalone procedure, OMNI combined with cataract surgery
- Keywords
- glaucoma, open-angle glaucoma, cataract, glaucoma surgery, ophthalmology, OMNI
- Medical subject headings
- Glaucoma, Open-Angle, Cataract, Eye Diseases, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNI as a standalone procedureProcedure or surgery
It uses a single, self-sealing clear corneal incision with ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System as a standalone procedure.
OMNI combined with cataract surgeryProcedure or surgery
Phacoemulsification with intraocular lens implantation is performed. Then, ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System.
| Study group | Role | What they receive |
|---|---|---|
| OMNI as a standalone procedure | Active comparator | Not described Receives: Procedure: OMNI as a standalone procedure |
| OMNI combined with cataract surgery | Active comparator | Not described Receives: Procedure: OMNI combined with cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes with a 20% reduction from baseline in IOP at 12 months on the same number, or fewer, ocular hypotensive medications as at the pre-operative baseline
Measured: 1 year
Number of Participants wih Postoperative complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start17 Apr 2018
- Primary completion3 Dec 2019
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- To prospectively assess the clinical effect of ab-interno transluminal viscodilation and trabeculotomy performed using the OMNI Surgical System as a standalone procedure or in combination with cataract extraction on intraocular pressure (IOP) and the use of ocular hypotensive medications in patients with open-angle glaucoma (OAG).
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Grabska- Liberek, Centre of Postgraduate Medical Education
- Investigators
- Iwona Grabska-Liberek, MD, PhD, Principal investigator, Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503356
- Sponsor's protocol ID
- 44/PB/2018
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the New Surgical Method OMNI in the Treatment of Adult Patients With Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT04503356
- Acronym / sponsor ID
- 44/PB/2018
- Conditions
- Open Angle Glaucoma, Cataract, Eye Diseases, Glaucoma
- Keywords
- glaucoma, open-angle glaucoma, cataract, glaucoma surgery, ophthalmology, OMNI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 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.
This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures.
Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To prospectively assess the clinical effect of ab-interno transluminal viscodilation and trabeculotomy performed using the OMNI Surgical System as a standalone procedure or in combination with cataract extraction on intraocular pressure (IOP) and the use of ocular hypotensive medications in patients with open-angle glaucoma (OAG).
| Arm | Type | Receives |
|---|---|---|
| OMNI as a standalone procedure | Active comparator | Procedure: OMNI as a standalone procedure |
| OMNI combined with cataract surgery | Active comparator | Procedure: OMNI combined with cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma
- 0-3 topical ocular hypotensive medications at preoperative baseline. Fixed combinations counted as number of components
- Open angles (Shaffer grade ≥3)
- early or moderate glaucoma (based on visual field)
- Subjects with a combined procedure should have had uncomplicated cataract surgery (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence of zonular dehiscence or rupture, well centered IOL)
Key exclusion criteria (9 listed)
- Any of the following prior treatments for glaucoma:
- Forms of glaucoma other than OAG including: acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Under treatment with oral carbonic anhydrase inhibitor at the preoperative visit
- Clinically significant ocular pathology, other than age-related cataract and glaucoma. (e.g. wet AMD, uveitis, corneal edema, proliferative diabetic retinopathy, optic neuritis in medical history)
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 as a standalone procedureIt uses a single, self-sealing clear corneal incision with ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System as a standalone procedure. | Procedure or surgery | OMNI as a standalone procedure |
| OMNI combined with cataract surgeryPhacoemulsification with intraocular lens implantation is performed. Then, ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System. | Procedure or surgery | OMNI combined with cataract surgery |
Primary outcome
Proportion of eyes with a 20% reduction from baseline in IOP at 12 months on the same number, or fewer, ocular hypotensive medications as at the pre-operative baseline
Time frame: 1 year
Number of Participants wih Postoperative complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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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.
Iwona Grabska-Liberek, MD, PhD principal investigator
Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland
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 as a standalone procedure and OMNI combined with cataract surgery in people with Open Angle Glaucoma and Cataract, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 5 inclusion and 9 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 11 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 Poland. 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?
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?
Proportion of eyes with a 20% reduction from baseline in IOP at 12 months on the same number, or fewer, ocular hypotensive medications as at the pre-operative baseline (time frame: 1 year). 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 11 Aug 2020.