Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With 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: Canaloplasty Device.
- Who it may be relevant to
- Registry conditions: OAG - Open-Angle Glaucoma. Basic parameters: from 22 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
- Chile, Costa Rica, Honduras
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery
Overview
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma
Interventions
- Device Canaloplasty Device
Canaloplasty
Primary outcome measures
- IOP change [Time frame: Month12]
Secondary outcome measures (2)
- IOP [Time frame: Month12]
- IOP meds [Time frame: Month12]
Eligibility criteria
Inclusion criteria
- Subjects qualifying for cataract surgery
- Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.
Exclusion criteria
1\. Patients who cannot be washed-out of IOP-lowering medications.
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
Chile · 1 center
- Centro de la Vision — Santiago
Costa Rica · 1 center
- Clínica 20/20 — San José
Honduras · 1 center
- Centro Oftalmologico Robles — Santa Rosa de Copán
Identifiers
NCT: NCT05696561 · DF12-CL-22-01