Clinical trial NCT05629078: Vision and Balance Changes After Bilateral Implantation of Toric IOLs
Official title: Vision and Balance Changes After Bilateral Implantation of Toric Versus Non-Toric Intraocular Lenses in Cataract Patients With Astigmatism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract Bilateral
Astigmatism Bilateral
Keywords: toric intraocular lens
dynamic stability
balance
post-cataract surgery
fear of falling
visual function
quality of life
Lead sponsor: University of Plymouth
Sponsor class: OTHER
Collaborators: name: Carl Zeiss Meditec AG
name: Glasgow Caledonian University
name: University of St Mark and St John Plymouth
name: University Hospital Plymouth NHS Trust
First posted: 2022-11-29
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised control trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Jerk from the centre of mass Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Jerk from the centre of mass Visit 2
timeFrame: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
measure: Jerk from the centre of mass Visit 3
timeFrame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Secondary outcomes:
measure: Unaided vision Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Unaided visionVisit 2
timeFrame: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
measure: Unaided vision Visit 3
timeFrame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Visual acuity Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Visual acuity Visit 2
timeFrame: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
measure: Visual acuity Visit 3
timeFrame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Mean spherical refraction Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Mean spherical refraction Visit 2
timeFrame: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
measure: Mean spherical refraction Visit 3
timeFrame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Astigmatic power J0 Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Astigmatic power J0 Visit 2
timeFrame: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
measure: Astigmatic power J0 Visit 3
timeFrame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Astigmatic power J45 Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Astigmatic power J45 Visit 2
timeFrame: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
measure: Astigmatic power J45 Visit 3
timeFrame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Contrast sensitivity Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Contrast sensitivity Visit 2
timeFrame: First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
measure: Contrast sensitivity Visit 3
timeFrame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Rotation of IOL at visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Rotation of IOL at visit 2
timeFrame: First assessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery
measure: Rotation of IOL at visit 3
timeFrame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Tilt of IOL at Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Tilt of IOL at Visit 2
timeFrame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Tilt of IOL at Visit 3
timeFrame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Centration of IOL at Visit 1
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Centration of IOL at Visit 2
timeFrame: assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery
measure: Centration of IOL at Visit 3
timeFrame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Fear of falling
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Fear of falling
timeFrame: assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery
measure: Fear of falling
timeFrame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Risk of fall
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Risk of fall
timeFrame: assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery
measure: Risk of fall
timeFrame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
measure: Cataract related quality of life
timeFrame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
measure: Cataract related quality of life
timeFrame: assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery
measure: Cataract related quality of life
timeFrame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Royal Eye Infirmary
Study officials:
affiliation: Royal Eye Infirmay, University Hosptials Plymouth NHS Trust
name: Nabil Habib, MB ChB(Hons)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Plymouth
name: Phillip Buckhurst, PhD
role: STUDY_CHAIR
affiliation: Glasgow Caledonian Unviersity
name: Catriona MacLennan, PhD
role: STUDY_DIRECTOR
affiliation: Plymouth Marjon University
name: Gary L.K. Shum, PhD
role: STUDY_DIRECTOR
affiliation: University of Plymouth
name: Hetal Buckhurst, PhD
role: STUDY_DIRECTOR
References: