Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
17 participants
INTERVENTIONAL
2018-04-17
2021-12-31
Brief Summary
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Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OMNI as a standalone procedure
OMNI as a standalone procedure
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 surgery
OMNI combined with cataract 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.
Interventions
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OMNI as a standalone procedure
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 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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Centre of Postgraduate Medical Education
OTHER
Responsible Party
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Iwona Grabska- Liberek
Professor
Principal Investigators
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Iwona Grabska-Liberek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland
Locations
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Orlowski Hospital, Centre of Postgraduate Medical Education
Warsaw, , Poland
Countries
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Other Identifiers
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44/PB/2018
Identifier Type: -
Identifier Source: org_study_id
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