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OMNI in Open-angle Glaucoma Treatment

Primary Purpose

Open Angle Glaucoma, Cataract, Eye Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

OMNI as a standalone procedure

OMNI combined with cataract surgery

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring glaucoma, open-angle glaucoma, cataract, glaucoma surgery, ophthalmology, OMNI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Orlowski Hospital, Centre of Postgraduate Medical Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

OMNI as a standalone procedure

OMNI combined with cataract surgery

Arm Description

Outcomes

Primary Outcome Measures

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

Number of Participants wih Postoperative complications

Secondary Outcome Measures

Full Information

NCT ID

NCT04503356

First Posted

August 4, 2020

Last Updated

August 7, 2020

Sponsor

Centre of Postgraduate Medical Education

1. Study Identification

Unique Protocol Identification Number

NCT04503356

Brief Title

OMNI in Open-angle Glaucoma Treatment

Official Title

Evaluation of the Effectiveness of the New Surgical Method OMNI in the Treatment of Adult Patients With Open-angle Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 17, 2018 (Actual)

Primary Completion Date

December 3, 2019 (Actual)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre of Postgraduate Medical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma, Cataract, Eye Diseases, Glaucoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OMNI as a standalone procedure

Arm Type

Active Comparator

Arm Title

OMNI combined with cataract surgery

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

OMNI as a standalone procedure

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

OMNI combined with cataract surgery

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

Number of Participants wih Postoperative complications

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iwona Grabska-Liberek, MD, PhD

Organizational Affiliation

Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orlowski Hospital, Centre of Postgraduate Medical Education

City

Warsaw

ZIP/Postal Code

00-401

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

OMNI in Open-angle Glaucoma Treatment

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