Clinical Outcomes in Cataract Surgery With OMNI Canaloplasty vs Cataract Surgery With OMNI Canaloplasty and Hydrus Stent
Running, not enrolling · Not applicable
Conditions studied: Glaucoma, Open-Angle
In brief
The goal of this clinical trial is to look at the difference in pressure lowering effects in patients having two different combinations of minimally invasive glaucoma surgery (MIGS) at the time of their cataract surgery. Eligible patients will have mild to moderate glaucoma and be candidates for cataract surgery. The trial will look at the eye pressure before and one year after cataract surgery in patients. One eye in each patient will have cataract surgery with canaloplasty using OMNI. The patients other eye will have cataract surgery with canaloplasty and a HYDRUS stent. The trial will look at the differences in eye pressure and if patients are able to need fewer eye pressure lowering drops after surgery. Study participants will undergo preop testing of pressure, vision, slit lamp exam, ocular coherence tomography (OCT) of the nerve fiber layer (NFL) analysis, and visual field prior to cataract surgery with MIGS. One day, one week, one month, 6 month, and 1 year exams will be performed to check pressure, vision, slit lamp exam, and number of necessary eye pressure medications in each eye.
Key facts
- Study ID
- NCT05949242
- Run by
- Ridge Eye Care
- People needed
- 80
- Starts
- 2023-04-07
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2025-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects with bilateral mild to moderate open angle glaucoma:
- Including pseudoexfoliation (PXE) and pigment dispersion (PDS) According to ICD-10 guidelines and with visual field (VF) mean deviation -12 decibels (dB) or better With visually significant age-related cataract undergoing uncomplicated cataract surgery Able to randomize first eye to either treatment group, contralateral eye to receive other treatment Fairly symmetric glaucoma with cup to disc (C/D) asymmetry ≤ 0.1 and similar OCT RNFL and VF mean deviation IOP ≥ 20 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s); ≤3mmHg between the eyes Central corneal thickness (CCT) 480 to 620µm No prior ocular surgery including corneal refractive surgery; No selective laser trabeculoplasty (SLT) within 3 months of baseline visit, no history of intracameral implants Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively
You may not qualify if…
- Subjects with secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma) Uncontrolled intraocular pressure on maximum tolerated medical therapy; unable to wash-out intraocular pressure (IOP) lowering drops Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities leading to poor angle visualization H/o corneal disease or dystrophy Pathological myopia with degeneration that affects diagnostic imaging Clinically significant ocular pathology or degenerative diseases that affect vision, humphrey visual field (HVF), or OCT Inability to perform reliable HVF /OCT
Where it is running
- Royo Eye Care — Marysville, California, United States
- Table Mountain Eye Care — Oroville, California, United States
- Ridge Eye Institute — Paradise, California, United States
- Feather River Eye Care — Yuba City, California, United States
Full record on ClinicalTrials.gov
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