Clinical trial NCT04503356: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Open Angle Glaucoma
Cataract
Eye Diseases
Glaucoma
Keywords: glaucoma
open-angle glaucoma
cataract
glaucoma surgery
ophthalmology
OMNI
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: 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
timeFrame: 1 year
measure: Number of Participants wih Postoperative complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Orlowski Hospital, Centre of Postgraduate Medical Education
Study officials:
affiliation: Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland
name: Iwona Grabska-Liberek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: