Efficacy and Safety of Posterior Chamber Glaucoma Drainage Device

NCT07003685 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 320/BVM-HDDD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Ahmed glaucoma valve (AGV) implantation in the posterior chamber (ciliary sulcus) compared with the traditional anterior chamber placement in patients with refractory pseudophakic glaucoma, who are adults (\>18 years), have undergone cataract surgery with intraocular lens implantation, and are unresponsive to maximal medical therapy. The main questions it aims to answer are: Does posterior chamber AGV implantation effectively lower intraocular pressure (IOP) compared to anterior chamber implantation? Does posterior chamber AGV implantation result in less corneal endothelial cell loss and lower rates of postoperative complications compared to anterior chamber implantation? Researchers will compare the two groups: Intervention group: AGV implantation in the posterior chamber (ciliary sulcus) Control group: AGV implantation in the anterior chamber Participants will: Undergo a baseline evaluation, including ocular examination, IOP measurement, corneal endothelial cell density (ECD) and variability, visual field testing, and optic nerve imaging. Be randomized into two groups based on a computer-generated randomization method. Receive either posterior chamber or anterior chamber AGV implantation. Be followed postoperatively at specified intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months) for IOP, use of glaucoma medications, visual acuity (Snellen, logMAR), corneal ECD, and endothelial cell variability (CV). Undergo regular assessments for postoperative complications such as hypotony, choroidal detachment, hyphema, infection, and device-related issues. Provide informed consent after explanation of potential risks and benefits of the procedure. This study will use a prospective, randomized controlled clinical trial design, enrolling at least 29 eyes in each group, conducted at the Glaucoma Department of Ho Chi Minh City Eye Hospital from March 2024 to March 2027

Conditions

Refractory Glaucoma

Outcome Measures

Primary Outcomes (2)

• IOP

  IOP change at 12 months postoperatively

• ECD

  Corneal endothelial cell density (ECD) change from baseline to 12 months

Study Arms (2)

Anterior chamber

ACTIVE COMPARATOR

Control group

Device: GDD in aterior chamber

Study group

EXPERIMENTAL

AGV in Posterior chamber

Device: GDD in posterior chamber

Interventions

GDD in posterior chamber DEVICE

GDD in posterior chamber

Study group

GDD in aterior chamber DEVICE

GDD in anterior chamber

Anterior chamber

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years.
• Diagnosis of refractory glaucoma (uncontrolled intraocular pressure despite maximal tolerated antiglaucoma medications).
• History of cataract extraction with intraocular lens implantation (pseudophakia).
• Agreement to participate in the study and ability to comply with outpatient follow-up requirements

You may not qualify if:

• Presence of corneal opacities that preclude accurate endothelial assessment.
• Co-existing corneal diseases that could affect endothelial cell status (e.g., Fuchs' dystrophy, corneal edema).
• Single-eye (monocular) status.
• Systemic medical conditions affecting coagulation or carrying increased surgical risk (e.g., uncontrolled diabetes, bleeding disorders)

Sponsors & Collaborators

• Eye Hospital of Ho Chi Minh City: lead

Study Sites (1)

Hochiminh city Eye Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Quyen Vo Mai Huynh, M.D.

  Ho Chi Minh city Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Head of General Planning Department

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 4, 2025
• Study Start: August 2, 2024
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): August 2, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Jun 2025 - Jun 2030
• Access Criteria: No criteria

Locations

VN (1)