Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VisiPlate Glaucoma Implant.
- Who it may be relevant to
- Registry conditions: Open Angle Glaucoma (OAG). Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial of the Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Overview
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Detailed description
To evaluate the safety and effectiveness of VisiPlate Aqueous Shunt to lower intraocular pressure (IOP) in subjects with open-angle glaucoma for whom medical and surgical treatments have failed.
Interventions
- Device VisiPlate Glaucoma Implant
Implant (micro-shunt) for glaucoma patients
Primary outcome measures
- Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure [Time frame: 12 Months]
Secondary outcome measures (1)
- Percentage change in mean diurnal IOP [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Open angle, pseudoexfoliative or pigmentary glaucoma
- IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg
- Visual field mean deviation score of -3dB or worse
- Area of healthy, free and mobile conjunctiva in the target quadrant
- Shaffer angle grade ≥ 2 in the target quadrant
Exclusion criteria
- Angle closure glaucoma
- Congenital, neovascular or other secondary glaucomas
- Previous intraocular surgery, with the exception of uncomplicated cataract surgery
- Previous glaucoma shunt/valve in the target quadrant
- Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit
- History of corneal surgery, corneal opacities or corneal disease
- Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- Arizona Advanced Eye Research — Glendale
- Sacramento Eye Consultants — Sacramento
- ICON Eye Care — Grand Junction
- Mile High Eye Institute — Sheridan
- Cleveland Clinic- Cole Eye Institute — Cleveland
- Scheie Eye Institute — Philadelphia
- Wills Eye Hospital — Philadelphia
- Glaucoma Associates of Texas — Dallas
- … and 2 more centers
South Africa · 2 centers
- Lynette Venter — Bloemfontein
- Pretoria Eye Institute — Pretoria
Identifiers
NCT: NCT07220876 · CP0005