Vision and Balance Changes After Bilateral Implantation of Toric IOLs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vision and Balance Changes After Bilateral Implantation of Toric Versus Non-Toric Intraocular Lenses in Cataract Patients With Astigmatism

Conditions
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Cataract Bilateral, Astigmatism Bilateral

Intervention / Treatment
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* Device: Toric intraocular lens Zeiss AT TORBI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bilateral significant corneal astigmatism >1.0D on waiting list for bilateral cataract surgery in NHS Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Toric Intraocular lens<br>Toric intraocular lens- AT TORBI® 709M, to be implanted bilaterally in the cataract surgery to correct astigmatism at the same time. | Device: Toric intraocular lens Zeiss AT TORBI<br>* Intraocular lenses are medical devices that are implanted in patients during cataract surgery. At Plymouth University NHS trust the standard lens is a monofocal non-Toric lens unless the patient has astigmatism greater than 4.00D. This study involves implantation of a toric lens in the intervention group where astigmatism is greater than 1.00D. The lens is called the toric IOLS- Zeiss AT TORBI, will be implanted bilaterally instead of standard monofocal IOLs- Zeiss CT ASPHINA, used in routine cataract surgery within NHS.<br>* Other names: Monofocal non-toric intraocular lens Zeiss CT ASPHINA 409/509M;|
| Active Comparator: Monofocal intraocular lens<br>Standard monofocals IOLs- Zeiss CT ASPHINA 409/509M, to be implanted bilaterally in the standard NHS cataract surgery without correcting the astigmatism. | Device: Toric intraocular lens Zeiss AT TORBI<br>* Intraocular lenses are medical devices that are implanted in patients during cataract surgery. At Plymouth University NHS trust the standard lens is a monofocal non-Toric lens unless the patient has astigmatism greater than 4.00D. This study involves implantation of a toric lens in the intervention group where astigmatism is greater than 1.00D. The lens is called the toric IOLS- Zeiss AT TORBI, will be implanted bilaterally instead of standard monofocal IOLs- Zeiss CT ASPHINA, used in routine cataract surgery within NHS.<br>* Other names: Monofocal non-toric intraocular lens Zeiss CT ASPHINA 409/509M;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jerk from the centre of mass Visit 1 | Assessed during functional activities using accelerometers | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Jerk from the centre of mass Visit 2 | Assessed during functional activities using accelerometers | First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery | 
| Jerk from the centre of mass Visit 3 | Assessed during functional activities using accelerometers | Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unaided vision Visit 1 | Unaided vision measured on a LogMAR acuity chart | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Unaided visionVisit 2 | Unaided vision measured on a LogMAR acuity chart | First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery | 
| Unaided vision Visit 3 | Unaided vision measured on a LogMAR acuity chart | Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Visual acuity Visit 1 | Aided vision measured on a LogMAR acuity chart | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Visual acuity Visit 2 | Aided vision measured on a LogMAR acuity chart | First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery | 
| Visual acuity Visit 3 | Aided vision measured on a LogMAR acuity chart | Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Mean spherical refraction Visit 1 | Mean spherical refraction assessed through subjective refraction | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Mean spherical refraction Visit 2 | Mean spherical refraction assessed through subjective refraction | 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 | Mean spherical refraction assessed through subjective refraction | Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Astigmatic power J0 Visit 1 | J0 assessed through subjective refraction and expressed in vector form | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Astigmatic power J0 Visit 2 | J0 assessed through subjective refraction and expressed in vector form | 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 | J0 assessed through subjective refraction and expressed in vector form | Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Astigmatic power J45 Visit 1 | J45 assessed through subjective refraction and expressed in vector form | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Astigmatic power J45 Visit 2 | J45 assessed through subjective refraction and expressed in vector form | First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery | 
| Astigmatic power J45 Visit 3 | J45 assessed through subjective refraction and expressed in vector form | Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Contrast sensitivity Visit 1 | Contrast sensitivity measured in log units | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Contrast sensitivity Visit 2 | Contrast sensitivity measured in log units | First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery | 
| Contrast sensitivity Visit 3 | Contrast sensitivity measured in log units | Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Rotation of IOL at visit 1 | Rotation of IOL relative to operation | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Rotation of IOL at visit 2 | Rotation of IOL relative to operation | First assessment 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 | Rotation of IOL relative to Operation | Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Tilt of IOL at Visit 1 | Tilt of IOL assessed using image analysis | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Tilt of IOL at Visit 2 | Tilt of IOL assessed using image analysis | assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Tilt of IOL at Visit 3 | Tilt of IOL assessed using image analysis | assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Centration of IOL at Visit 1 | Centration of IOL assessed using image analysis | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Centration of IOL at Visit 2 | Centration of IOL assessed using image analysis | assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery | 
| Centration of IOL at Visit 3 | Centration of IOL assessed using image analysis | assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Fear of falling | Fear of falling measured using revised fear of falling questionnaire (FFR) | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Fear of falling | Fear of falling measured using revised fear of falling questionnaire (FFR) | assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery | 
| Fear of falling | Fear of falling measured using revised fear of falling questionnaire (FFR) | assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Risk of fall | Risk of fall in daily activities measured by Short Fall Efficacy Scale Questionnaire (Short FFS-I) | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Risk of fall | Risk of fall in daily activities measured by Short Fall Efficacy Scale Questionnaire (Short FFS-I) | assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery | 
| Risk of fall | Risk of fall in daily activities measured by Short Fall Efficacy Scale Questionnaire (Short FFS-I) | assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 
| Cataract related quality of life | Using Catract patient reported outcome measure CAT-PROM5 questionnaire | Baseline assessment will be carried out at study visit 1 before the cataract surgery | 
| Cataract related quality of life | Using Catract patient reported outcome measure CAT-PROM5 questionnaire | assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery | 
| Cataract related quality of life | Using Catract patient reported outcome measure CAT-PROM5 questionnaire | assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toric intraocular lens, dynamic stability, balance, post-cataract surgery, fear of falling, visual function, quality of life