None listed
Conditions
Interventions
SINGLE GROUP Type of group
ALL SUBJECTS RECEIVE DEVICE.
Sponsors
MM INSTRUMENTOS S.A.C.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign and date an informed consent document in accordance with the GCP guidelines and local regulations approved by a Research Ethics Committee where all aspects of the protocol are explained. 2. The subject must be 18 years of age or older. 3. The subject must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is not controllable with the maximum tolerated medical treatment with ocular hypotensive drugs or who has failed in traditional glaucoma surgery or who is not considered a reasonable candidate for traditional surgery. 4. A documented IOP of the subject should be considered by the treating physician to be too high for their glaucoma status. 5. The subject must have, in the study eye, a BCVA between 20/50 and light perception, or not have light perception with pain greater than 03 on a scale of 00 to 10, where, 00 is no pain, 05 is moderate pain and 10 is very severe pain. 6. The subject should have a BCVA in the other eye better than that of the study eye. 7. The subject must be mentally competent and willing to give informed consent. 8. Subject must be willing to return for all study visits and evaluations for at least one (1) year after surgery.
Exclusion criteria
Exclusion criteria: 1. Subjects who have participated in the past three months, are participating, or plan to participate in a study with any investigational agent (drug or device). 2. Subjects with serious pulmonary or cardiovascular disorders, progressive stage cancer, chronic unstable diseases or acute diseases that may influence the evaluation of the study. 3. Pregnant women. 4. Subjects with a diagnosis of glaucoma other than open-angle glaucoma, including recent uveitic, active neovascular, or recent traumatic glaucoma. 5. Subjects with a clinically significant corneal condition, including corneal dystrophy. 6. Subjects with iridocorneal endothelial syndrome. 7. Subjects with an anterior chamber configuration that puts them at high risk for developing angle-closure glaucoma. 8. Subjects with any recent eye or periocular inflammation or infection in the past 30 days. 9. Subjects with a history of considerable keloid formation. 10. Subjects requiring ancillary procedures in the study eye at the time of implantation or during the first year of the study period. 11. Subjects with any known intolerance or hypersensitivity to topical anesthetics, mydriatics or device components. 12. Subjects who cannot discontinue their anticoagulant, antiplatelet, or NSAID therapy (including aspirin) for at least one (1) week prior to surgery. 13. Researchers, medical center staff directly affiliated with this study and their immediate relatives. An immediate family member is defined as a spouse, parent, child, or descendant, whether biological or legally adopted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Goldmann applanation tonometry Measure:Proportion of patients achieving at least a 20% reduction in IOP in 6 months after surgery, with respect to the baseline value. Timepoints:Basal Value (visit 1) and Visit 10 (Week 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Goldmann applanation tonometry Measure:Proportion of patients achieving at least a 20% reduction in IOP in 12 months after surgery, with respect to the baseline value. Timepoints:Basal Value (visit 1) and Visit 13 (Week 48). ; Outcome name:Goldmann applanation tonometry Measure:Proportion of patients maintain a target IOP at 6 months post-surgery, and at 12 months post-surgery, that is, they have an IOP between 10 and 21 mm Hg. Timepoints:Basal Value (visit 1), visit 10 (week 24) and visit 13 (week 48) ; Outcome name:Goldmann applanation tonometry Measure:Basal IOP, and at the time of measurement Visit 5 (1 Week), Visit 6 (Week 4), Visit 8 (Week 12), Visit 10 (Week 24), Visit 12 (Week 36) and Visit 13 (Week 48). Timepoints:Basal Value (visit 1), Visit 5 (1 Week), Visit 6 (Week 4), Visit 8 (Week 12), Visit 10 (Week 24), Visit 12 (Week 36) and Visit 13 (Week 48). ; Outcome name:Goldmann applanation tonometry Measure:Percentage change of IOP at 24 weeks (6 months post-surgery.) Timepoints:Basal Value (visit 1) and Visit 10 (Week 24). ; Outcome name:Goldmann applanation tonometry Measure:Percentage change of IOP at 48 weeks (approximately 1 year post-surgery). Timepoints:Basal Value (visit 1) and Visit 13 (Week 48). ; Outcome name:Visual field, BCVA and manifest refraction. Measure:Change of basal values at 6 months and at 12 months with respect to baseline values of visual field, BCVA and manifest refraction. Timepoints:Basal Value (visit 1), visit 10 (week 24) and visit 13 (week 48) ; Outcome name:Ophthalmological examination (includes pain assessment), slit lamp biomicroscopy, indirect ophthalmoscopy and gonioscopy. Measure:Distribution of basal frequencies, at 6 months and 12 months post-surgery: ophthalmological examination (includes pain assessment), slit lamp biomicroscopy, indirect ophthalmoscopy and gonioscopy. Timepoints:Basal Value (visit 1), visit 1 | — |
Countries
Peru
Contacts
Public ContactNIEVES MILAGROS SOLANO
CIENTIFICA CRO SAC
Outcome results
None listed