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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01314170
• Other study ID #: E01-ADA-VSUS-01-10
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 4, 2010
• Last updated: May 9, 2011
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: May 2011
• Source: Adapt Produtos Oftalmológicos Ltda.
• Contact: Augusto Paranhos, Investigator
• Phone: 55 11 3747-3312
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Susanna Implant
device

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Adapt Produtos Oftalmológicos Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma.	Evaluate the effectiveness of implant susanna in patients with refractory glaucoma.	180 days	Yes
Secondary	Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. "	Evaluate the safety of implant susanna in patients with refractory glaucoma. i	180 days	Yes