Visual and refractive outcomes and patient satisfaction real world evaluation following bilateral implantation of AcrySof IQ PanOptixToric IOL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Primary Endpoint: 3 Months post 2nd eye Surgery:-
研究概览
简要总结
Aprospective, interventional, non-randomized, single centre study to to characterize the visual outcomes of PanOptixToric Multifocal IOLimplanted to replace the natural lens in cataract patients. Trial population shall comprise of adult Indian subjects 18-70 years ofage at the time of informed consent with no ocular pathology with regularcorneal topography and corneal astigmatism from 0.75 D to 4.00 D who requirecataract extraction. 33 subjects fulfilling the inclusion and exclusioncriteria undergoing bilateral implantation of PanOptixToric IOL implantation (n=66)following cataract surgery to be performed by a single surgeon at NethradhamaSuper Speciality Eye Hospital, will be included in the study to provide real world evidence on visual and refractive outcomes, and patientsatisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D.
- •Best Corrected Visual Acuity to be 0.2 LogMAR or lower
- •Clear intraocular media
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures.
排除标准
- •Any active ocular disease
- •Diabetic retinopathy, retinal degenerative disorders, macular degeneration, glaucoma with field defects
- •Irregular corneal astigmatism( keratoconus/ PMD)
- •Previous intraocular and corneal refractive surgery
- •Pregnancy & Lactation
- •Traumatic , Intumescent and white Cataracts
- •Subject who have retinal pathologies or dystrophies and those who are expected to require retinal laser treatment
- •Concurrent participation in another drug or device study.
结局指标
主要结局
Primary Endpoint: 3 Months post 2nd eye Surgery:-
时间窗: Pre-opertative/ intra-opera visits and post-operative days 1, 15, 90, 180, 365
Corrected photopic distance visual acuity (CDVA, binocular)
时间窗: Pre-opertative/ intra-opera visits and post-operative days 1, 15, 90, 180, 365
次要结局
- 1. Uncorrected and corrected photopic distance, intermediate and near visual acuity(2. Improvement in Quality of Life (Quality of Life Questionnaire developed by Rasch Analysis))