Vision and Balance Changes After Bilateral Implantation of Toric Versus Non-Toric Intraocular Lenses in Cataract Patients With Astigmatism
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Jerk from the centre of mass Visit 2
研究概览
简要总结
Cataracts are the major cause of blindness in the world. Cataract surgery, being the most performed surgery in the world today, provide correction by extracting the natural lens from its capsular bag and replaced by an artificial intraocular lens (IOL) implantation. In the UK, almost all patients undergoing cataract surgery by the NHS are given monofocal intraocular lenses (IOLs) which do not correct corneal astigmatic error. It is estimated that around 20% of the population has over 1.50DC of corneal astigmatism. Uncorrected astigmatism not only increase spectacle dependency and reduce quality of life post surgically, but it also adversely affects the overall economic costs. Specialised toric IOLs offer the opportunity to correct pre-existing corneal astigmatism. Previous work has shown a link between reduced vision and balance or mobility. Full correction of refractive error may have greater impact on lifestyle than previously thought.
详细描述
This is a single centre, parallel randomized controlled trial study comparing the dynamic stability and visual outcomes of cataract patient with astigmatism implanted with mono-focal Toric versus non-Toric IOLs.
140 cataracts patients with astigmatism awaiting cataract correction surgery at the Royal Eye infirmary of the University Hospitals of Plymouth NHS Trust will be recruited in this study over a two year period. The participants will be randomly assigned to be implanted with either Toric IOLs or standard non-Toric IOLs. Three additional study visits will be arranged for them. One visit before the cataract surgery, second visit at three to six months after the first eye cataract surgery and third visit at three to six months after the second eye cataract surgery. The primary assessment outcome is dynamic balance measured by movement sensors (accelerometer) during walk and turn, crossing over obstacle and stair walking. The secondary outcomes include eye tracking during movement activities, visual functions, risk of fall questionnaires and vision-specific quality of life questionnaire.
This project is funded by Carl Zeiss Meditec AG, led by the University of Plymouth and sponsored by University Hospitals Plymouth NHS Trust . The project also involves collaboration with the University of Glasgow and the Plymouth Marjon University.
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 (Investigator)
盲法说明
investigators will be blinded to which types of IOLs implanted to the cataract patients
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bilateral significant corneal astigmatism >1.0D
- •on waiting list for bilateral cataract surgery in NHS
排除标准
- •pre-existing eye pathology which may be aggravated by intraocular implant
- •previous intraocular/ corneal surgery
- •History of uveitis, glaucoma, proliferative diabetic retinopathy or IDDM, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better
- •Micropthalmia
- •corneal decompensation or endothelial insufficiency
- •pars planitis
- •high myopia
- •participants using a systematic medication that is known to cause ocular side effects
- •participated in a concurrent clinical trial or have participated in an opthalmology clinical trial within the last 30 days
- •unable or not willing to cooperate for the follow up period
- •pregnant women
- •unable to give informed consent
- •unable to walk with or without walking aids independently for at least 20m
- •unable to walk up/down stairs independently using aids or handrail
研究组 & 干预措施
Toric Intraocular lens
Toric intraocular lens- AT TORBI® 709M, to be implanted bilaterally in the cataract surgery to correct astigmatism at the same time.
干预措施: Toric intraocular lens Zeiss AT TORBI (Device)
Monofocal intraocular lens
Standard monofocals IOLs- Zeiss CT ASPHINA 409/509M, to be implanted bilaterally in the standard NHS cataract surgery without correcting the astigmatism.
干预措施: Toric intraocular lens Zeiss AT TORBI (Device)
结局指标
主要结局
Jerk from the centre of mass Visit 2
时间窗: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
Assessed during functional activities using accelerometers
Jerk from the centre of mass Visit 1
时间窗: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Assessed during functional activities using accelerometers
Jerk from the centre of mass Visit 3
时间窗: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Assessed during functional activities using accelerometers
次要结局
- Rotation of IOL at visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Astigmatic power J0 Visit 2(First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery)
- Astigmatic power J0 Visit 3(Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Astigmatic power J45 Visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Astigmatic power J45 Visit 2(First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery)
- Rotation of IOL at visit 3(Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Contrast sensitivity Visit 2(First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery)
- Centration of IOL at Visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Centration of IOL at Visit 2(assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery)
- Centration of IOL at Visit 3(assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Cataract related quality of life(assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Unaided vision Visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Unaided vision Visit 3(Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Unaided visionVisit 2(First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery)
- Visual acuity Visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Visual acuity Visit 2(First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery)
- Astigmatic power J0 Visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Visual acuity Visit 3(Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Mean spherical refraction Visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Mean spherical refraction Visit 2(First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery)
- Mean spherical refraction Visit 3(Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Astigmatic power J45 Visit 3(Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Contrast sensitivity Visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Contrast sensitivity Visit 3(Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Rotation of IOL at visit 2(First assessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery)
- Tilt of IOL at Visit 1(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Tilt of IOL at Visit 2(assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Tilt of IOL at Visit 3(assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Fear of falling(assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Risk of fall(assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery)
- Fear of falling(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Fear of falling(assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery)
- Risk of fall(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Risk of fall(assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery)
- Cataract related quality of life(Baseline assessment will be carried out at study visit 1 before the cataract surgery)
- Cataract related quality of life(assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery)
研究者
Dr Phillip J Buckhurst
Professor
University of Plymouth