Glaucoma
Conditions
Keywords
Implant, glaucoma, refractory glaucoma.
Brief summary
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna Implant in patients with refractory glaucoma.
Detailed description
Clinical trial multicenter, phase III,open-label, prospective character to evaluate the efficacy and safety of Susanna Implant in patients with refractory glaucoma of both genders, of any race, aged above 18 years and diagnosed with glaucoma refractory.
Interventions
DEVICESusanna Implant
device
Sponsors
Adapt Produtos Oftalmológicos Ltda.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Neovascular glaucoma group: 1. Patient with neovascular glaucoma whose intraocular pressures which must be above 21 in at least three measurements, at different times in at least two different days during one month, despite maximum tolerated medical therapy. 2. Visual acuity better than hand movements in the study eye. 3. Patients 18 years or more. 4. Patients with fixed residence in the health district where the surgery will be performed. 5. Patients who fit the term of consent. Group post-trabeculectomy failure: 1. Patients diagnosed with primary open angle glaucoma, pseudoesfoliação, pigmented or primary angle closure who underwent surgery with trabeculectomy procedure after failure of at least two months of surgery. The pressure must be above 21 in at least three measurements, at different times in at least two different days during one month, despite maximum tolerated medical therapy. 2. Patients diagnosed with primary open angle glaucoma, pseudoesfoliação, pigmented or primary angle closure who underwent surgery with trabeculectomy procedure after failure of at least two months for surgery and who can not afford the expenses of medical treatment. The pressure must be above 21 in at least three measurements, at different times in at least two different days during one month. 3. Visual acuity better than hand movements in the study eye. 4. Patients 18 years or more. 5. Patients with fixed residence in the health district where the surgery will be performed. 6. Patients who fit the term of consent.
Exclusion criteria
Group post-trabeculectomy failure: 1. Presence of staphyloma that does not allow the procedure. 2. Presence of history of scleritis 3. Presence of psychiatric disorder that has required hospitalization. 4. Presence of retinal detachment surgery with placement of a buckle or track. 5. Presence of corneal opacity that could prevent the adequate view of the anterior chamber. 6. Presence of shallow anterior chamber that would prevent the placement of the implant. 7. Presence of vitreous in aphakia or anterior chamber. 8. Presence of psychiatric disorder that has required hospitalization. Neovascular glaucoma group: 1. Presence of staphyloma that does not allow the procedure. 2. Presence of history of scleritis. 3. Presence of corneal opacity that could prevent the adequate view of the anterior chamber. 4. Presence of shallow anterior chamber that would prevent the placement of the implant. 5. Presence of vitreous in aphakia or anterior chamber. 6. Presence of retinal detachment surgery with placement of a buckle or track. 7. Presence of neovascular glaucoma or other secondary glaucoma. 8. Presence of psychiatric disorder that has required hospitalization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. | 180 days | Evaluate the effectiveness of implant susanna in patients with refractory glaucoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. | 180 days | Evaluate the safety of implant susanna in patients with refractory glaucoma. i |
Countries
Brazil
Contacts
Primary ContactAugusto Paranhos, Investigator
Backup ContactFernanda Lima, Coordinator
Outcome results
None listed