Clinical Outcomes in Cataract Surgery With OMNI Canaloplasty vs Cataract Surgery With OMNI Canaloplasty and Hydrus Stent

NCT05949242 | Active Not Recruiting FDA Device

• 1 other identifier: 76998263
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this clinical trial is to look at the difference in pressure lowering effects in patients having two different combinations of minimally invasive glaucoma surgery (MIGS) at the time of their cataract surgery. Eligible patients will have mild to moderate glaucoma and be candidates for cataract surgery. The trial will look at the eye pressure before and one year after cataract surgery in patients. One eye in each patient will have cataract surgery with canaloplasty using OMNI. The patients other eye will have cataract surgery with canaloplasty and a HYDRUS stent. The trial will look at the differences in eye pressure and if patients are able to need fewer eye pressure lowering drops after surgery. Study participants will undergo preop testing of pressure, vision, slit lamp exam, ocular coherence tomography (OCT) of the nerve fiber layer (NFL) analysis, and visual field prior to cataract surgery with MIGS. One day, one week, one month, 6 month, and 1 year exams will be performed to check pressure, vision, slit lamp exam, and number of necessary eye pressure medications in each eye.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• change in unmedicated intraocular pressure from baseline at 12 months

  check intraocular pressure at start date and at 12 months after washout of all pressure controlling drops

  12 months

Secondary Outcomes (2)

• reduction in number of medications needed to control intraocular pressure from baseline

  12 months

• percentage of patients with greater than 20% reduction in intraocular pressure from baseline

  12 months

Study Arms (2)

OMNI canaloplasty with cataract surgery

ACTIVE COMPARATOR

participant will undergo OMNI canaloplasty with cataract surgery in one randomized eye

Device: OMNI canaloplasty

OMNI canaloplasty and Hydrus with cataract surgery

ACTIVE COMPARATOR

participant will undergo OMNI canaloplasty and Hydrus with cataract surgery in the contralateral eye

Device: OMNI canaloplasty; Device: Hydrus microstent

Interventions

OMNI canaloplasty DEVICE

OMNI device is used to catheterize Schlemm's canal for 180 degrees and perform canaloplasty. Viscoelastic is eluded upon retraction of the catheter performing viscodilation of the canal

OMNI canaloplasty and Hydrus with cataract surgery; OMNI canaloplasty with cataract surgery

Hydrus microstent DEVICE

Hydrus stent is introduced into Schlemm's canal to scaffold open the canal

OMNI canaloplasty and Hydrus with cataract surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with bilateral mild to moderate open angle glaucoma:
• Including pseudoexfoliation (PXE) and pigment dispersion (PDS) According to ICD-10 guidelines and with visual field (VF) mean deviation -12 decibels (dB) or better With visually significant age-related cataract undergoing uncomplicated cataract surgery Able to randomize first eye to either treatment group, contralateral eye to receive other treatment Fairly symmetric glaucoma with cup to disc (C/D) asymmetry ≤ 0.1 and similar OCT RNFL and VF mean deviation IOP ≥ 20 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s); ≤3mmHg between the eyes Central corneal thickness (CCT) 480 to 620µm No prior ocular surgery including corneal refractive surgery; No selective laser trabeculoplasty (SLT) within 3 months of baseline visit, no history of intracameral implants Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively

Sponsors & Collaborators

• Ridge Eye Care: lead
• Alcon Research: collaborator

Study Sites (4)

Royo Eye Care

Marysville, California, 95901, United States

Location

Table Mountain Eye Care

Oroville, California, 95966, United States

Location

Ridge Eye Institute

Paradise, California, 95969, United States

Location

Feather River Eye Care

Yuba City, California, 95991, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Douglas McGraw, DO

  Ridge Eye Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will have one eye randomized to each arm of the trial: one eye will receive OMNI canaloplasty alone the other eye will receive OMNI canaloplasty and Hydrus microstent

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 17, 2023
• Study Start: April 7, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)