A Clinical Trial Comparing the OMNI Surgical System to Standard Medical Treatment in Pseudophakic Eyes (EVOLVE)

Sight Sciences

Status and phase: Enrolling; Phase 4

Conditions: Primary Open Angle Glaucoma

Treatments: Drug: Latanoprost plus adjunctive glaucoma medication; Device: OMNI Surgical System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06407973

09074

Details and patient eligibility

About

A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment in Pseudophakic Patients with Primary Open Angle Glaucoma (EVOLVE)

Full description

This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS in pseudophakic patients with POAG with DIOP ≥ 20 mmHg on prostaglandin monotherapy.

Enrollment: 334 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects, 45 years or older.
2. History of uncomplicated cataract surgery and posterior chamber intraocular lens (IOL) implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit.
3. Under treatment with a topical prostaglandin F2 analog (e.g. latanoprost, travoprost, bimatoprost, tafluprost) as monotherapy for a minimum of 3 months prior to the Screening visit.
4. Intraocular pressure (IOP) at the Screening visit of 20 mmHg or more and not exceeding 36 mmHg.
5. Diagnosed with primary open angle glaucoma (POAG).

Exclusion criteria

1. Any of the following prior ocular procedures:

   • Laser trabeculoplasty ≤180 days prior to baseline
   • Durysta ≤12 months prior to baseline
   • Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device; or
   • Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, endoscopiccyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe)
   • Retinal laser procedure ≤3 months prior to baseline

2. Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)

3. Forms of glaucoma other than POAG including but not limited to: Pigmentary, pseudoexfoliative, acute angle closure, normal tension, pre-perimetric, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subject's medical record.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

Surgical (OMNI Surgical System (OSS))

Active Comparator group

Description:

Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.

Treatment:

Device: OMNI Surgical System

Standard Medical Care (SMC)

Active Comparator group

Description:

Standard Medical Care with Latanoprost and an adjunctive glaucoma medication at the discretion of the Principal Investigator

Treatment:

Drug: Latanoprost plus adjunctive glaucoma medication