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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
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.
Royal Eye Infirmary
Plymouth, United Kingdom
RECRUITINGJerk from the centre of mass Visit 1
Assessed during functional activities using accelerometers
Time frame: 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
Time frame: 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
Time frame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Unaided vision Visit 1
Unaided vision measured on a LogMAR acuity chart
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Contrast sensitivity Visit 2
Contrast sensitivity measured in log units
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
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