Clinical trial NCT01314170: Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.
Official title: Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucoma
Keywords: Implant, glaucoma, refractory glaucoma.
Lead sponsor: Adapt Produtos Oftalmológicos Ltda.
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma.
timeFrame: 180 days
Secondary outcomes:
measure: Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. "
timeFrame: 180 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital das Clínicas de São Paulo
name: Remo Susanna, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIFESP - Universidade Federal de São Paulo
name: Renato Lisboa, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitário Prof. Edgar Santos - BA
name: Cláudia Galvão, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: - Instituto brasileiro de Oftalmologia e prevenção da cegueira- BA
name: Flávia Villas, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitário São José - Belo Horizonte
name: Fábio Kanadani, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein
name: Augusto Paranhos, Investigator
role: PRINCIPAL_INVESTIGATOR
References: