Compares where a glaucoma drainage valve is placed in adults with hard-to-control glaucoma
Tests valve placement behind the iris in adults with glaucoma after cataract surgery.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Posterior Chamber Glaucoma Drainage Device
Key facts
- Where
- Ho Chi Minh City, VietnamSee the site
Where in Vietnam
- Hochiminh city Eye HospitalHo Chi Minh City, VietnamNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eye Hospital of Ho Chi Minh City
- Trial code
- NCT07003685
- Record updated
- 11 August 2025
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Posterior Chamber Glaucoma Drainage Device in Refractory Pseudophakic Glaucoma Patients
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
Inclusion: 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.
Exclusion: Co-existing corneal diseases that could affect endothelial cell status (e.g., Fuchs' dystrophy, corneal edema); Systemic medical conditions affecting coagulation or carrying increased surgical risk (e.g., uncontrolled diabetes, bleeding disorders); Presence of corneal opacities that preclude accurate endothelial assessment; Single-eye (monocular) status.