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NCT04530084 Clinical Trial

A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System

Open Angle Glaucoma Clinical Trial

Official title:
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04530084
Other study ID # 1290569
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 21, 2020
Est. completion date December 2021

Study information
Verified date August 2020
Source El Paso Eye Surgeons
Contact Mark Gallardo, MD
Phone (915) 542-0279
Email gallardomark@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall objective of this study is to determine the safety and usability of OMNI surgical system in performing canaloplasty and trabeculotomy. Outcome measures will include 1) adverse events (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive medications

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2021
Est. primary completion date August 22, 2021
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria:

1. Male or female subjects, 22 years or older.

2. Visually significant cataract or pseudophakic with a posterior chamber intraocular lens (PCIOL)

3. Diagnosed with open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma)

4. Scheduled for canaloplasty and trabeculotomy

Exclusion Criteria:

1. Any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract.

2. Prior trabeculectomy, other bleb-forming glaucoma surgery (e.g. tube shunt), or implanted trabecular bypass stents.

3. Any other ocular pathologies that may interfere with the study procedure or be exacerbated by the OMNI procedure.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OMNI Surgical System
Scheduled for canaloplasty and trabeculotomy with or without cataract extraction

Locations
Country Name City State
United States El Paso Eye Surgeons El Paso Texas

Sponsors (1)
Lead Sponsor Collaborator
Mark Gallardo, MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events (intraoperative and perioperative) 3 months
Primary Best Corrected Visual Acuity (BCVA) 3 months
Secondary Mean intraocular pressure (IOP) 3 months
Secondary Mean number of ocular hypotensive medications 3 months
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