Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Binocular visual acuity for far, intermediate and near distance
研究概览
简要总结
The aim of this study is to evaluate the visual function of patients with bilateral implantation of the IOL trifocal ZEISS AT LISA TRI AND TRI TORIC by means of visual acuity tests with and without optical correction, sensitivity curve contrast, defocus curve and quality questionnaire visual function (VFQ-25).
详细描述
Twenty patients (40 eyes) diagnosed with cataracts and cataract surgery indication will be selected to participate in this study. The surgery will be performed by the same surgeon with 2 week interval between surgery the first and second eye. After approval of the research project by the Research Ethics Committee all patients should understand and sign the Informed Consent and Informed (IC) before surgery.
All patients will be operated by conventional phacoemulsification with implantation of intraocular lens provided by the manufacturer.
Patients will have five study visits, including the preoperative visit, operative visit four postoperative visits.
All patients will be submitted to the following routine assessments preoperatively and demographic patient information will be recorded and a detailed medical history will be obtained.
- VFQ-25 Questionnaire
- Identification of the dominant eye;
- Visual acuity
- Refraction
- Slit lamp examination
- Tonometry
- Self-keratometry;
- Corneal topography;
- Microscopy speculate
- Fundus examination.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 50 years
- •Cataract diagnosis indicating surgery in both eyes
- •Corneal astigmatism to 12D (AT lisa tri toric)
- •Corneal astigmatism less than 0,75D (AT lisa tri)
- •Ability to provide consent and clarification for study participation
排除标准
- •Significant irregular corneal astigmatism as shown by Corneal topography;
- •Corneal astigmatism up 12D
- •Patients diagnosed with severe visual degenerative disorders (e.g. macular degeneration or other disorder of the retina)
- •Previous corneal surgery;
- •Amblyopia
- •Planning for multiple procedures, including IRL, LASIK, etc. during surgery or during the study
- •Endothelial dystrophy clinically significant cornea (eg, Fuchs dystrophy)
- •Corneal disease activity (eg, herpes simplex, herpes zoster, etc.)
- •Severe diabetic retinopathy
- •Retinal detachment
- •Patients presenting illness or acute conditions or chronic severe that in the opinion of the investigator, would increase the surgical risk or confound the research results
- •Any patient who is taking part in another study involving ocular surgery
研究组 & 干预措施
AT LISA TRI TORIC
All patients will be undergo to phacoemulsification with IOL implantation bilateral
干预措施: AT LISA TRI TORIC (Device)
AT LISA TRI
All patients will be undergo to phacoemulsification with IOL implantation bilateral
干预措施: AT LISA TRI (Device)
结局指标
主要结局
Binocular visual acuity for far, intermediate and near distance
时间窗: Changes from Pre-Op to Month 3
Visual acuity measurements
次要结局
- Defocus Curve(Month 3)
- Contrast Sensitivity(Changes from Pre-Op and Month 3)
- VFQ-25 Questionnaire(Changes from Pre-Op and Month 3)
研究者
Rubens Belfort Jr.
Professor
Federal University of São Paulo