A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System
|
Device: OMNI® Surgical System
Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
| Active Comparator: Ab-interno transluminal viscoelastic delivery using OMNI surgical System
|
Device: OMNI® Surgical System
Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
| Active Comparator: iStent Inject implantation
|
Device: iStent inject
Trabecular meshwork implantation
|
Outcome Measures
Primary Outcome Measures
- Mean change in unmedicated DIOP from baseline at 12-month postoperative examination [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects, 22 years or older
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Visually significant cataract
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Mild to moderate open angle glaucoma
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On 1-5 IOP-lowering medications
Exclusion Criteria:
Any of the following prior treatments for glaucoma:
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Laser trabeculoplasty ≤3 months prior to baseline
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Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
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Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record.
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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 (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eye Center South | Dothan | Alabama | United States | 36301 |
| 2 | Eye Associates and SurgiCenter of Vineland | Vineland | New Jersey | United States | 08361 |
Sponsors and Collaborators
- Sight Sciences, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07024