OMNI in Open-angle Glaucoma Treatment

Not Applicable

• Conditions: Cataract; Glaucoma; Eye Diseases; Open Angle Glaucoma
• Interventions: Procedure: OMNI as a standalone procedure; Procedure: OMNI combined with cataract surgery

• Registration Number: NCT04503356
• Lead Sponsor: Centre of Postgraduate Medical Education

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Primary Completion: 2019-12-03
• Status Verified: 2020-08
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-07
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMNI as a standalone procedure	OMNI as a standalone procedure	-
OMNI combined with cataract surgery	OMNI combined with cataract surgery	-

Primary Outcome Measures

Name	Time	Method
Number of Participants wih Postoperative complications	1 year
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

Trial Locations

Locations (1)

Orlowski Hospital, Centre of Postgraduate Medical Education; 🇵🇱 Warsaw, Poland