Status:
UNKNOWN
OMNI in Open-angle Glaucoma Treatment
Lead Sponsor:
Centre of Postgraduate Medical Education
Conditions:
Open Angle Glaucoma
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
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 gla...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04503356
Start Date
April 17 2018
End Date
December 1 2021
Last Update
August 11 2020
Active Locations (1)
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1
Orlowski Hospital, Centre of Postgraduate Medical Education
Warsaw, Poland, 00-401