A Randomised, Controlled Study to Compare Visual Performance Following Bilateral, Micro-monovision Insertion of Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: The TECNIS Eyhance® ICB00 and the Alcon IQ SN60WF Lenses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in Cost Benefits from baseline to 6 months
研究概览
简要总结
In an aging population, cataract and presbyopia become increasingly common. A cataract develops when the natural crystalline lens inside a person's eye, becomes cloudy over time, causing reduction of vision. Presbyopia is an age related condition resulting in loss of reading/near vision and requiring reading glasses.
Cataract surgery is the most common elective surgery in the world for patients over 65. It is composed of removal the cataract and insertion of a new intraocular lens (IOL). Currently only monofocal IOLs are available on the NHS (National Health Service, United Kingdom) - meaning they give good distance or near vision. The majority of patients opt for good distance vision with glasses to read.
The investigators are trialling insertion of a new Extended Depth of Focus (enhanced aspheric) IOL (EDoF IOL), which treats both cataract and presbyopia. All patients attending St Thomas' hospital for treatment of cataracts will be considered for invitation to the study.
Patients who participate in the study will be randomly selected to receive either the new Extended Depth of Focus IOL - the TECNIS Eyhance ICB00 IOL, or a well-established monofocal (non-EDoF) IOL the Alcon Acrysof IQ SN60WF IOL during cataract surgery. Insertion of the Alcon Acrysof IQ SN60WF IOL is known to treat cataract but not presbyopia.
Patients will be assessed and have their surgery performed at St Thomas' Hospital London. They will have 7 appointments over 12 months, plus surgery. The investigators hope to demonstrate better distance, intermediate and near vision and increased spectacle independence in the TECNIS Eyhance ICB00 IOL group.
EDoF IOLs have the potential to improve cataract surgery outcomes for patients in the NHS.
详细描述
This study is a clinical trial, designed to compare visual outcomes after cataract surgery with two different intraocular lenses. As previously described, modern day cataract surgery is composed of two main components: removal of the cataract, and insertion of an intraocular lens (IOL). The role of the intraocular lens is to replace the focusing power of the natural crystalline lens inside the eye. It is this lens that becomes a cataract. Removing a cataract alone helps light enter the eye, but does not focus it well. Prior to the invention of intraocular lenses, patients required extremely thick and strong glasses for both distance and near vision.
Currently only monofocal intraocular lenses are available on the NHS. Different strengths of lens can be chosen to give the patient good distance, intermediate or near vision. That means the ability to focus on objects in the distance, middle distance or near. Most patients opt for good distance vision, enabling them to mobilise easily, watch TV and drive, and require glasses for reading.
As described above, most patients over the age of 50, have some element of presbyopia, which is the inability to focus on near objects, resulting in the need for reading glasses. Inserting extended depth of focus (EDoF IOLs) intraocular lenses during cataract surgery, can help improve their reading vision without reading glasses.
The TECNIS Eyhance ICB00 IOL is a new EDoF IOL which has an enhanced depth of focus through its novel 'enhanced aspheric' design. This will help treat presbyopia. The Alcon Acrysof IQ SN60WF IOL is an established IOL which gives good monofocal vision, i.e. good distance or near vision, but not both.
Our trial will investigate the effect of a new Extended depth of focus lens on vision and compare it to a commonly used Monofocal IOL. The investigators will recruit patients who have bilateral cataracts. These patients will have otherwise healthy eyes. Patients who have been referred to St Thomas' Hospital for assessment for cataracts will be considered for the trial. If they fulfil the criteria for acceptance to the trial, the consulting doctor will discuss this with the patient. If the patient expresses interest, they will be referred to the Research department. The cataract research fellow will review them and consider them for admission to the trial. This review will happen on the day of the original appointment, or the patient will be given an another appointment time and date for further assessment. If a patient would like further information about the study, but cannot speak to the Cataract Research Fellow that same day, they will be asked to fill in a Consent to Contact form, which will allow the research department to contact the patient for consideration for entry to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patient will not be informed of which arm of the study they will be allocated to.
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral cataract requiring surgical intervention, age over 18 years able to understand informed consent and the objectives of the trial, not pregnant, not breast feeding no previous intraocular eye surgery good visual potential in both eyes corneal astigmatism of less than 1.5 diopters
排除标准
- •Any patient with other ocular condition that might reduce visual acuity and hence confound the results such as:
- •visually impairing age-related macular degeneration
- •Advanced glaucoma
- •previous retinal vascular disorders
- •previous retinal detachment or tear
- •any visually impairing neuro-ophthalmological condition
- •any inherited retinal disorder or pathology
- •previous strabismus surgery or record of amblyopia
- •previous visually impairing CVA, TIA or other vaso-occlusive disease
- •already enrolled in another study or trial
- •instability of keratometry or biometry measurements
- •irregular astigmatism
- •previous significant trauma to eye
- •age over 100
结局指标
主要结局
Change in Cost Benefits from baseline to 6 months
时间窗: 6 months after cataract surgery
Patient related cost benefits in terms of spectacle expenditure.
Change in Refractive Error from baseline to 6 months
时间窗: 6 months after cataract surgery
Optometrist assessed refractive error for Near, and distance vision
Change in Cost Benefits from baseline to 6 weeks
时间窗: 6 weeks after cataract surgery
Patient related cost benefits in terms of spectacle expenditure.
Change in Visual Acuity from baseline to 6 weeks
时间窗: 6 weeks after cataract surgery
Uniocular \& Binocular, Unaided and Best Corrected, Near, intermediate and distance vision
Change in Visual Acuity from baseline to 6 months
时间窗: 6 months after cataract surgery
Uniocular \& Binocular, Unaided and Best Corrected, Near, intermediate and distance vision
Change in Refractive Error from baseline to 6 weeks
时间窗: 6 weeks after cataract surgery
Optometrist assessed refractive error for Near, and distance vision
Change in Patient Satisfaction from baseline to 6 months
时间窗: baseline and 6 months after cataract surgery
patient satisfaction - PROM questionnaire: EQ-5D-3L scores A 2 part questionnaire 1. 5 questions, with 3 options each. Each question is scored 1 to 3, with the cumulative assessment described as a 5 digit code. 2. The second part asks patients to estimate their health on the day of the questionnaire on a numerical and visual scale ranging from 0 (worst health possible) to 100 (best health imaginable).
Change in Patient Satisfaction from baseline to 6 weeks
时间窗: baseline and 6 weeks after cataract surgery
Patient satisfaction - PROM questionnaire: EQ-5D-3L scores A 2 part questionnaire 1. 5 questions, with 3 options each. Each question is scored 1 to 3, with the cumulative assessment described as a 5 digit code. 2. The second part asks patients to estimate their health on the day of the questionnaire on a numerical and visual scale ranging from 0 (worst health possible) to 100 (best health imaginable).
次要结局
- Change in Contrast Sensitivity at 6 weeks after surgery(6 weeks after cataract surgery)
- Change in Contrast Sensitivity at 6 months after surgery(6 months after cataract surgery)
- Documentation of Post-operative complications(6 months after cataract surgery)
- Documentation of Post-operative complications 2 weeks after surgery(2 weeks after cataract surgery)
- Change in Stereoacuity at 6 weeks after cataract surgery(6 weeks after the second cataract surgery)
- Change in Stereoacuity at 6 months after cataract surgery(6 months after the second cataract surgery)
- Documentation of Post-operative complications 6 weeks after surgery(6 weeks after cataract surgery)
