NCT01314170Unknown3 期
Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma.
研究概览
简要总结
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna Implant in patients with refractory glaucoma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neovascular glaucoma group:
- •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.
- •Visual acuity better than hand movements in the study eye.
- •Patients 18 years or more.
- •Patients with fixed residence in the health district where the surgery will be performed.
- •Patients who fit the term of consent.
- •Group post-trabeculectomy failure:
- •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.
- •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.
- •Visual acuity better than hand movements in the study eye.
- •Patients 18 years or more.
- •Patients with fixed residence in the health district where the surgery will be performed.
- •Patients who fit the term of consent.
排除标准
- •Group post-trabeculectomy failure:
- •Presence of staphyloma that does not allow the procedure.
- •Presence of history of scleritis
- •Presence of psychiatric disorder that has required hospitalization.
- •Presence of retinal detachment surgery with placement of a buckle or track.
- •Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
- •Presence of shallow anterior chamber that would prevent the placement of the implant.
- •Presence of vitreous in aphakia or anterior chamber.
- •Presence of psychiatric disorder that has required hospitalization.
- •Neovascular glaucoma group:
- •Presence of staphyloma that does not allow the procedure.
- •Presence of history of scleritis.
- •Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
- •Presence of shallow anterior chamber that would prevent the placement of the implant.
- •Presence of vitreous in aphakia or anterior chamber.
- •Presence of retinal detachment surgery with placement of a buckle or track.
- •Presence of neovascular glaucoma or other secondary glaucoma.
- •Presence of psychiatric disorder that has required hospitalization.
结局指标
主要结局
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma.
时间窗: 180 days
Evaluate the effectiveness of implant susanna in patients with refractory glaucoma.
次要结局
- Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. "(180 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in TaiwanCenter-involved Diabetic Macular EdemaNCT04288232Taipei Veterans General Hospital, Taiwan45
招募中
3 期
Phase IIIb Study of Ribociclib + ET in Early Breast CancerEarly Breast CancerNCT05827081Novartis Pharmaceuticals1,400
Unknown
3 期
Safety,Efficacy and Pharmacokinetics Evaluation of SCT800 in Previously Treated Paediatric Patients With Severe Haemophilia A.Hemophilia ANCT03947320Sinocelltech Ltd.70
进行中（未招募）
3 期
Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCCHepatocellular CarcinomaNCT05557838AstraZeneca214
进行中（未招募）
3 期
Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLCALK-positiveSAF-189sNon-Small Cell Lung CancerNCT06569420Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.275