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Efficacy and Safety of Posterior Chamber Glaucoma Drainage Device

NCT07003685 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-11

No results posted yet for this study

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

Interventions

DEVICE

GDD in posterior chamber

GDD in posterior chamber

DEVICE

GDD in aterior chamber

GDD in anterior chamber

Sponsors & Collaborators

  • Eye Hospital of Ho Chi Minh City

    lead OTHER

Principal Investigators

  • Quyen Vo Mai Huynh, M.D. · Ho Chi Minh city Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2027-08-02
Completion
2027-08-02
FDA Device
Yes

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07003685 on ClinicalTrials.gov