Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sight Sciences, Inc.
To assess the safety of the Helix Surgical System with cataract surgery and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG) and cataract.
Age
45–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects, 45 years or older
Visually significant age-related cataract.
Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months.
Diagnosed with mild to moderate primary open angle glaucoma (POAG).
You may not be if
Any of the following prior ocular procedures:
* Laser trabeculoplasty ≤180 days prior to baseline
* Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU),
* 180 days prior to baseline
* Retinal laser procedure ≤3 months prior to baseline
Any form of glaucoma other than POAG
Use of topical ocular steroids.
Clinically significant concurrent ocular pathology or systemic 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 or interfere with compliance to elements of the study protocol
History of penetrating keratoplasty or another corneal transplant
Endothelial cell density \< 2200 cells/mm2 (age 45), \< 2000 cells/mm2 (age 46 to 55), \< 1800 cells/mm2 (age 56 to 65), \< 1600 cells/mm2 (age \> 65).
Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract
BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
Clareo Health | A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)
