NCT01059162Unknown不适用
Evaluation of OT-135P (IOPtiMateTM) : Beam Manipulating System for CO2 Laser Assisted Non-Penetrating Glaucoma Surgery
IOPtima Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intra-Ocular Pressure (IOP)
研究概览
简要总结
The aim of the study is to evaluate the safety and effectiveness of the IOPtiMate (OT-135P) in Laser Assisted Non-Penetrating Glaucoma surgery in Open-Angle and Pseudoexfoliative Glaucoma patients.
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
- 否
入选标准
- •Patient must be 18 years of age or older.
- •Patient must have primary open angle glaucoma or pseudo-exfoliative glaucoma in the study eye; diagnosis is based on glaucomatous optic neuropathy, Shaffer angle of +2 and visual field defect attributed to glaucoma (at least two consecutive abnormal visual field test results, defined as a pattern SD (PSD) outside the 95% normal confidence limits and/or glaucoma Hemifield Test (Carl Zeiss Meditec, Inc.).
- •Eye to be treated must be phakic or pseudophakic eye with no ocular disorder or ocular diseases but cataract, and no prior surgical intervention in study eye but cataract surgery with clear corneal incision and trabeculoplasty performed > 3 months ago.
- •Patient is indicated for filtration surgery.
- •Presence of ocular hypertension, defined as an intraocular corrected pressure (IOP) ≥ 21 mm Hg in the study eye, while on maximal tolerated medications . This IOP level of above or equal 21 mmHg must be verified and recorded in the most recent 2 consecutive measurements (but not taken on the same day) prior to operation.
- •Best corrected visual acuity (BCVA) better than 20/200 in the fellow eye.
- •Optic neuropathy is attributed exclusively to glaucoma.
- •Patient or legal guardian agrees to sign written informed consent prior to study participation.
- •Patient is able and willing to complete post-operative follow-up requirements.
排除标准
- •Patient has previously undergone a non-penetrating glaucoma surgery with the IOPtima CO2 Laser System in fellow eye.
- •Diagnosis of glaucoma other than primary open angle glaucoma or pseudo-exfoliative glaucoma.
- •History of previous intraocular surgery in the study eye; referring to but not limited to glaucoma filtering surgery (penetrating and non-penetrating), laser gonioplasty, corneal transplant, and history of any other laser ocular procedures except for laser trabeculoplasty surgery.
- •Laser trabeculoplasty surgery within the last three months in the study eye.
- •Study eye is aphakic.
- •Patients with previous cataract extraction with scleral tunnel and or conjunctival incision in the study eye.
- •Proliferative or severe non-proliferative retinopathy in either eye.
- •Eyes with (dilated) pupil diameter of less than 2 mm in the study eye.
- •Discernable congenital anomaly of the anterior chamber angle in the study eye.
- •Patients with neuropathy other than glaucoma in the study eye.
- •Patient with RVO (retinal vein occlusion) in the study eye.
- •Patient with RAO (retinal artery occlusion) in the study eye.
- •History of prior vitrectomy or Vitreous Hemorrhage (VH) in the study eye.
- •Patient with media opacification which may interfere with optic nerve evaluation in the study eye.
- •Patient with a history of severe eye trauma in the study eye
- •Patient with ocular malformations such as microphthalmia in the study eye.
- •Patient with concurrent inflammatory / infective eye disorder (e.g. episcleritis, scleritis) in the study eye
- •Patient with any sign of past or present uveitis (anterior / posterior)
- •Patient with known allergy to the study medications.
- •Patient with severe systemic disease or disabling conditions such as: chronic renal failure requiring dialysis, severe and disenabling neurological disease, and post organ transplants.
- •Patient participating in another clinical trial or participation in another clinical trial is < 3 months.
- •Patient is pregnant or breast feeding. Women of child bearing age will submit a urine sample result for β-HCG (Pregnancy test) within 2 weeks of surgery.
结局指标
主要结局
Intra-Ocular Pressure (IOP)
时间窗: 6 months
次要结局
- Number of anti-Glaucoma Medications(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™WrinklePigmented LesionsNCT04727099Candela Corporation50
Unknown
不适用
Enhanced Safety Laser Hair Removal SystemHirsutismHypertrichosisNCT00441948Scilex Ltd.10
Unknown
不适用
Enhanced Safety Aesthetic Laser SystemHirsutismTelangiectasesRhytidesHypertrichosisNCT00495443Scilex Ltd.25
招募中
不适用
Evaluation of the use of Laser-ILIB to improve pain and change in sensitivity in patients with Diabetic NeuropathyDiabetic polyneuropathyDiabetic mononeuropathyDiabetic neuropathyRBR-3bth6y2Faculdade de Farmácia da Universidade Federal da Bahia
已完成
不适用
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro PlusPseudofolliculitis BarbaeUnwanted HairPigmented LesionsVascular LesionWrinkleAcneOnychomycosisNCT04993066Candela Corporation77