Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.

Adapt Pharma

Status and phase: Unknown; Phase 3

Conditions: Glaucoma

Treatments: Device: Susanna Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01314170

E01-ADA-VSUS-01-10

Details and patient eligibility

About

Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna Implant in patients with refractory glaucoma.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Susanna Implant

No Intervention group

Description:

Patients with refractory glaucoma neovascular type or that failed in trabeculectomy will undergo surgery to place implants Susana.

Treatment:

Device: Susanna Implant