Not yet recruiting NCT06809647
A Prospective Interventional Cohort Study to Evaluate the Efficacy and Safety of the AquaLumen, a Novel Filtration Procedure for the Treatment of 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: Glaucoma surgery.
- Who it may be relevant to
- Registry conditions: Glaucoma Open-Angle. Basic parameters: from 18 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
- 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 →
Overview
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.
Interventions
- Device Glaucoma surgery
This is an implant-free, minimally invasive glaucoma surgery
Primary outcome measures
- Intra Ocular pressure [Time frame: 12 months]
- Use of concomitant topical glaucoma medications [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Moderate to severe open angle glaucoma
- Central corneal thickness between 480 and 610 microns
Exclusion criteria
- surgical history of corneal graft
- presence of corneal opacities
- Failed prior trabeculectomy
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 · 1 center
- MUSC Storm Eye Institute — Charleston
Identifiers
NCT: NCT06809647 · PLU-01