An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.

N/AEnrolling By InvitationNCT06230393

New World Medical, Inc.20 enrolled

Overview

The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM

A Retrospective, nonrandomized, open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE® SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Open Angle Glaucoma Intraocular Pressure

Interventions

STREAMLINE® SURGICAL SYSTEMDEVICE

STREAMLINE® SURGICAL SYSTEM

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: participated in the DF6-CL-20-01 trial. Exclusion Criteria: lost to follow up in the DF6-CL-20-01 trial

Locations (1)

Clinica 20/20

San José, Costa Rica

Outcomes

Primary Outcomes

Change in IOP

From Screening to annual endpoints

Time frame: 24months; 36 months; 48months, 60 months

Secondary Outcomes

Number of IOP lowering medications

Compared to screening in DF6-CL-20-01 trial

Time frame: 24months; 36 months; 48months, 60 months

Data from ClinicalTrials.gov

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