Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT03861169
Eligibility Criteria:
Inclusion Criteria:
Only one eye of each subject was eligible (the "study eye"), and all ocular criteria listed below applied to the study eye.
1. Male or female subjects, 22 years or older
2. Visually significant cataract
3. Diagnosed with mild to moderate open-angle glaucoma (e.g., primary open-angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record per ICD-10 guidelines
4. At screening, a medicated IOP ≤ 33 mmHg and on 1-4 IOP-lowering medications1 with a stable medication regimen for two months prior to screening visit
5. At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher than screening IOP
6. Scheduled for cataract extraction followed by ab- interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System
7. Shaffer grade of ≥ 3 in all four quadrants
8. Potential of good best corrected visual acuity post cataract extraction, in the Investigator's judgment
9. Able and willing to comply with the protocol, including all follow-up visits.
10. Understood and signed the informed consent
Exclusion Criteria:
All criteria listed below applied to the study eye; both eyes of a single subject need not have been eligible for the study.
1. Any of the following prior treatments for glaucoma:
* Laser trabeculoplasty ≤ 3 months prior to baseline
* Implanted with iStent, CyPass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
* Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
2. Normal tension glaucoma
3. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
4. Severe glaucoma as documented in subjects' medical record per ICD-10 guidelines
5. Use of oral hypotensive medication treatment for glaucoma
6. In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
7. Ocular pathology or medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)
8. Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator
9. Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03861169
Study Brief:
Protocol Section:
NCT03861169