OMNI in Open-angle Glaucoma Treatment

NCT04503356 | Unknown

• 1 other identifier: 44/PB/2018
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Open Angle Glaucoma; Cataract; Eye Diseases; Glaucoma

Keywords

glaucoma; open-angle glaucoma; cataract; glaucoma surgery; ophthalmology; OMNI

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Interventions

OMNI as a standalone procedure 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 as a standalone procedure

OMNI combined with cataract surgery PROCEDURE

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.

OMNI combined with cataract surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Orlowski Hospital, Centre of Postgraduate Medical Education

Warsaw, 00-401, Poland

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract; Eye Diseases; Glaucoma

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Ocular Hypertension; Lens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Iwona Grabska-Liberek, MD, PhD

  Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: April 17, 2018
• Primary Completion: December 3, 2019
• Study Completion: December 1, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

PL (1)