OMNI in Open-angle Glaucoma Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma; Eye Diseases; Cataract; Open Angle Glaucoma
• Intervention / Treatment: Procedure: OMNI as a standalone procedure; Procedure: OMNI combined with cataract surgery

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OMNI as a standalone procedure	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.
Active Comparator: OMNI combined with cataract surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 year
Number of Participants wih Postoperative complications	1 year

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education
• Investigators: Principal Investigator: Iwona Grabska-Liberek, MD, PhD, Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): December 3, 2019
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: cataract; open-angle glaucoma; glaucoma; ophthalmology; glaucoma surgery; OMNI
• Additional Relevant MeSH Terms: Ocular Hypertension; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Eye Diseases; Cataract
• Other Study ID Numbers: 44/PB/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No