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Status unknownNCT04503356Updated Aug 11, 2020

OMNI in Open-angle Glaucoma Treatment

An interventional study of OMNI as a standalone procedure and OMNI combined with cataract surgery in Open Angle Glaucoma, Cataract and Eye Diseases, sponsored by Centre of Postgraduate Medical Education. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by Centre of Postgraduate Medical Education · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Apr 2018, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 phacoemulsification cataract procedures.

Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.

02

Conditions studied

  • Open Angle Glaucoma
  • Cataract
  • Eye Diseases
  • Glaucoma

Keywords

  • glaucoma
  • open-angle glaucoma
  • cataract
  • glaucoma surgery
  • ophthalmology
  • OMNI
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 17 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Centre of Postgraduate Medical Education is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Active comparator
    OMNI as a standalone procedure

    Procedure: OMNI as a standalone procedure

  • Active comparator
    OMNI combined with cataract surgery

    Procedure: OMNI combined with cataract surgery

Interventions

  • ProcedureOMNI 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.

  • ProcedureOMNI 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. Number of Participants wih Postoperative complications

    Time frame: 1 year

07

Study locations

1 site
  • Orlowski Hospital, Centre of Postgraduate Medical Education
    Warsaw, 00-401, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04503356
Lead sponsor
Centre of Postgraduate Medical Education
Responsible party
Iwona Grabska- Liberek (Professor, Centre of Postgraduate Medical Education) — Principal investigator
First posted
Aug 7, 2020
Start date
Apr 17, 2018
Primary completion
Dec 3, 2019
Completion
Dec 2021 (estimated)
Last update
Aug 11, 2020

Study contacts

Iwona Grabska-Liberek, MD, PhD
principal investigator · Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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