Clinical trial NCT04658095: Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)
Official title: A Prospective, Randomized, Multicenter Study To Compare The Safety And Effectiveness Of The OMNI® Surgical System And The iStent Inject In Pseudophakic Eyes With Open Angle Glaucoma. The TRIDENT European Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, 18 years or older
2. Pseudophakic
3. Diagnosis of open angle glaucoma (OAG)
4. On 1-5 ocular hypotensive medications

Exclusion Criteria:

1. Any of the following prior treatments for glaucoma:

   * Suprachoroidal stent (e.g. Cypass, iStent Supra)
   * Laser trabeculoplasty ≤ 8 weeks prior to Baseline visit with a MIGS or other glaucoma device including but not limited to iStent, iStent inject, Hydrus, CyPass
   * Trabeculectomy or other bleb forming procedure including Xen, PreserFlo, Express, glaucoma draining device/valve
   * Prior canaloplasty, goniotomy, or trabeculotomy including procedures with GATT, Kahook Dual Blade, iTrack, Trabectome
   * Ciliary ablation procedures including Endocyclophotocoagulation (ECP), Cyclophotocoagulation (G probe), Micropulse laser, or high intensity focused ultrasound (HIFU)
2. Any other form of glaucoma other than OAG
3. 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).
4. 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.

Primary outcomes:
measure: Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: BurgerHospital
city: Barcelona
country: Spain
facility: Institut Catala de Retina (ICR)
city: Valencia
country: Spain
facility: Universidad Complutense de Madrid
city: Zaragoza
country: Spain
facility: Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
Study officials:
References: