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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04658095
Other study ID # 07062
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 14, 2021
Est. completion date August 9, 2022

Study information

Verified date August 2022
Source Sight Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date August 9, 2022
Est. primary completion date August 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OMNI® Surgical System
Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy using the OMNI Surgical System
iStent inject
Ab-interno implantation of iStent inject (2 microstents)
OMNI® Surgical System
Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System

Locations

Country Name City State
Germany BurgerHospital Frankfurt
Spain Institut Catala de Retina (ICR) Barcelona
Spain Universidad Complutense de Madrid Valencia
Spain Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle Zaragoza
United Kingdom Manchester Royal Eye Hospital Manchester

Sponsors (1)

Lead Sponsor Collaborator
Sight Sciences, Inc.

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination 12 months
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