OMNI in Open-angle Glaucoma Treatment

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04503356
• Other study ID #: 44/PB/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: December 2021
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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
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.

Locations

Country	Name	City	State
Poland	Orlowski Hospital, Centre of Postgraduate Medical Education	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants wih Postoperative complications		1 year