Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Visual acuity after 3 months post operatively
研究概览
简要总结
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with advancing technologies and a wider selection of lenses available, demand for improved outcomes, improved lens design and ease of surgical implantation have increased. The purpose of this study is to assess the visual performance of the EyeCee One monofocal intraocular lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.
详细描述
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. There are many different designs of monofocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. This research project allows us to assess the visual outcomes of a specific monofocal IOL. It also allows us to assess the ease of use of the lens to the surgeon.
Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month post implantation), Visit 2 (3 months post implantation).
At both post-operative visits the patient will undergo:
Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications
At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens insertion time and ease of use.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically significant Cataract requiring cataract surgery
排除标准
- •Amblyopia
- •Corneal astigmatism of >1.00D
- •Dilated pupil size smaller than 5mm
- •Macular pathology
- •Retinal disease
- •Corneal disease
- •Abnormal iris
- •Pupil deformation
- •Any previous corneal or intraocular surgery
- •Any patient who had surgical complications will also be excluded from participation in the study.
结局指标
主要结局
Visual acuity after 3 months post operatively
时间窗: 3 months post operatively
Visual acuity measured in LogMAR measured 3 months post operatively
Visual acuity early post operative
时间窗: 1 month post operatively
Visual acuity measured in LogMAR early post operatively
次要结局
- Ease of use to surgeons(During surgery)
研究者
Dr Phillip J Buckhurst
Associate Head of School for Research
University of Plymouth