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

Not yet recruiting

• Conditions: Open Angle Glaucoma; Intraocular Pressure

• Registration Number: NCT06230393
• Lead Sponsor: New World Medical, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-30
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13
• Study Start: 2024-03-01
• Primary Completion: 2029-04-30
• Study Completion: 2029-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

participated in the DF6-CL-20-01 trial.

Read More

Exclusion Criteria

lost to follow up in the DF6-CL-20-01 trial

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in IOP	24months; 36 months; 48months, 60 months	From Screening to annual endpoints

Secondary Outcome Measures

Name	Time	Method
Number of IOP lowering medications	24months; 36 months; 48months, 60 months	Compared to screening in DF6-CL-20-01 trial

Trial Locations

Locations (1)

Clinica 20/20; 🇨🇷 San José, Costa Rica