NCT06809647

Brief Summary

The study will follow a group of patients with glaucoma disease that undergo a surgical procedure intended to reduce the intra-ocular pressure (IOP) for a period of one year.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress78%
Mar 2025Aug 2026

First Submitted

Initial submission to the registry

January 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

January 30, 2025

Last Update Submit

January 30, 2025

Conditions

Glaucoma Open-Angle

Outcome Measures

Primary Outcomes (2)

  • Intra Ocular pressure

    12 months

  • Use of concomitant topical glaucoma medications

    12 months

Study Arms (1)

This is the group that will undergo the surgical treatment

EXPERIMENTAL
Device: Glaucoma surgery

Interventions

Glaucoma surgeryDEVICE

This is an implant-free, minimally invasive glaucoma surgery

This is the group that will undergo the surgical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe open angle glaucoma
  • Central corneal thickness between 480 and 610 microns

You may not qualify if:

  • surgical history of corneal graft
  • presence of corneal opacities
  • Failed prior trabeculectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUSC Storm Eye Institute

Charleston, South Carolina, 29424, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Carlos A Urrea, MD

CONTACT

215-327-5500CUrrea@pluophthalmic.com

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

January 30, 2025

First Posted

February 5, 2025

Study Start

March 30, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 5, 2025

Record last verified: 2025-01

Locations

US(1)