To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.
First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
Trabecular meshwork implantation
Eye Center South
Dothan, Alabama, United States
Eye Associates and SurgiCenter of Vineland
Vineland, New Jersey, United States
Change in Unmedicated Diurnal Intraocular Pressure (DIOP)
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Change in the Number of Ocular Hypotensive Medications Compared to Screening
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
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