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

Phase 3

• Conditions: Glaucoma
• Interventions: Device: Susanna Implant

• Registration Number: NCT01314170
• Lead Sponsor: Adapt Produtos Oftalmológicos Ltda.

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.

Study Timeline

• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Status Verified: 2011-05
• Study Start: 2011-05
• Last Update Submitted: 2011-05-09
• Last Update Posted: 2011-05-10
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Susanna Implant	Susanna Implant	Patients with refractory glaucoma neovascular type or that failed in trabeculectomy will undergo surgery to place implants Susana.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil