OMNI in Open-angle Glaucoma Treatment

Centre of Postgraduate Medical Education

Status

Unknown

Conditions

Cataract

Glaucoma

Open Angle Glaucoma

Eye Diseases

Treatments

Procedure: OMNI as a standalone procedure

Procedure: OMNI combined with cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04503356

44/PB/2018

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)