NCT04700189

Brief Summary

The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

December 18, 2020

Last Update Submit

May 9, 2023

Conditions

Intraocular PressureOpen Angle Glaucoma

Keywords

Intraocular PressureGlaucomaGlaucoma SurgeryAb interno

Outcome Measures

Primary Outcomes (1)

  • Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%

    Descriptive

    From Baseline at Month 12

Secondary Outcomes (2)

  • Changes from baseline in intraocular pressure (IOP)

    From Baseline at Month 12

  • Changes from baseline in number of IOP lowering medications

    From Baseline at Month 12

Study Arms (1)

Treatment with Streamline following cataract surgery

EXPERIMENTAL

Treatment with Streamline System following phacoemulsification

Device: ab interno canaloplasty

Interventions

ab interno canaloplastyDEVICE

A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.

Treatment with Streamline following cataract surgery

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must meet all the following criteria in order to be eligible for participation in this study:
  • Subjects qualifying for cataract surgery
  • Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg.

You may not qualify if:

  • Subjects are ineligible for participation in this study if s/he meets any of the following criteria:
  • Patients who could not be washed-out of IOP-lowering medications. .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Gabriel S. Lazcano Gomez

Puerto México, 72190, Mexico

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Gabriel Lozcano, MD

    Puebla, Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2020

First Posted

January 7, 2021

Study Start

December 4, 2020

Primary Completion

September 21, 2022

Study Completion

September 21, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

ME(1)