Cataract, Eye Diseases, Glaucoma, Open Angle Glaucoma
Conditions
Keywords
glaucoma, open-angle glaucoma, cataract, glaucoma surgery, ophthalmology, OMNI
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.
Interventions
PROCEDUREOMNI 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.
PROCEDUREOMNI 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.
Sponsors
Centre of Postgraduate Medical Education
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| 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 |
Countries
Poland
Outcome results
None listed