Cataract BilateralNCT05629078
Vision and Balance Changes After Bilateral Implantation of Toric IOLs
A study testing Toric intraocular lens Zeiss AT TORBI in people with Cataract Bilateral and Astigmatism Bilateral, run by University of Plymouth at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Cataract Bilateral, Astigmatism Bilateral
- What is being tested?
- Toric intraocular lens Zeiss AT TORBI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jan 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral significant corneal astigmatism >1.0D
- on waiting list for bilateral cataract surgery in NHS
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Eye Infirmary
Plymouth
Nabil Habib, nabil.habib@nhs.net
About this study
Official title: Vision and Balance Changes After Bilateral Implantation of Toric Versus Non-Toric Intraocular Lenses in Cataract Patients With Astigmatism
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.
Read the 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.
- Conditions
- Cataract Bilateral, Astigmatism Bilateral
- Being tested
- Toric intraocular lens Zeiss AT TORBI
- Keywords
- toric intraocular lens, dynamic stability, balance, post-cataract surgery, fear of falling, visual function, quality of life
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toric intraocular lens Zeiss AT TORBIDevice
Also called Monofocal non-toric intraocular lens Zeiss CT ASPHINA 409/509M
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.
| Study group | Role | What they receive |
|---|---|---|
| Toric Intraocular lens | Active comparator | Toric intraocular lens- AT TORBI® 709M, to be implanted bilaterally in the cataract surgery to correct astigmatism at the same time. Receives: Device: Toric intraocular lens Zeiss AT TORBI |
| Monofocal intraocular lens | Active comparator | Standard monofocals IOLs- Zeiss CT ASPHINA 409/509M, to be implanted bilaterally in the standard NHS cataract surgery without correcting the astigmatism. Receives: Device: Toric intraocular lens Zeiss AT TORBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jerk from the centre of mass Visit 1
Assessed during functional activities using accelerometers
Measured: 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
Measured: 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
Measured: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Secondary outcomes (36)
Unaided vision Visit 1
Unaided vision measured on a LogMAR acuity chart
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Contrast sensitivity Visit 2
Contrast sensitivity measured in log units
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start12 Jan 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised control trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec AG, Glasgow Caledonian University, University of St Mark and St John Plymouth, University Hospital Plymouth NHS Trust
- Responsible party
- Principal investigator, Dr Phillip J Buckhurst, University of Plymouth
- Investigators
- Nabil Habib, MB ChB(Hons), Principal investigator, Royal Eye Infirmay, University Hosptials Plymouth NHS TrustPhillip Buckhurst, PhD, Study chair, University of PlymouthCatriona MacLennan, PhD, Study director, Glasgow Caledonian UnviersityGary L.K. Shum, PhD, Study director, Plymouth Marjon UniversityHetal Buckhurst, PhD, Study director, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629078
- Sponsor's protocol ID
- 286913
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision and Balance Changes After Bilateral Implantation of Toric Versus Non-Toric Intraocular Lenses in Cataract Patients With Astigmatism
- ClinicalTrials.gov ID
- NCT05629078
- Acronym / sponsor ID
- 286913
- Conditions
- Cataract Bilateral, Astigmatism Bilateral
- Keywords
- toric intraocular lens, dynamic stability, balance, post-cataract surgery, fear of falling, visual function, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec AG, Glasgow Caledonian University, University of St Mark and St John Plymouth, University Hospital Plymouth NHS Trust
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Toric Intraocular lens | Active comparator | Device: Toric intraocular lens Zeiss AT TORBIToric intraocular lens- AT TORBI® 709M, to be implanted bilaterally in the cataract surgery to correct astigmatism at the same time. |
| Monofocal intraocular lens | Active comparator | Device: Toric intraocular lens Zeiss AT TORBIStandard monofocals IOLs- Zeiss CT ASPHINA 409/509M, to be implanted bilaterally in the standard NHS cataract surgery without correcting the astigmatism. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bilateral significant corneal astigmatism >1.0D
- on waiting list for bilateral cataract surgery in NHS
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toric intraocular lens Zeiss AT TORBIAlso: Monofocal non-toric intraocular lens Zeiss CT ASPHINA 409/509MIntraocular 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. | Device | Monofocal intraocular lens, Toric Intraocular lens |
Primary outcome
Jerk from the centre of mass Visit 1
Time frame: 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 2
Time frame: 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 3
Time frame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Assessed during functional activities using accelerometers
36 secondary outcomes
Unaided vision Visit 1
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Unaided visionVisit 2
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
Time frame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Visual acuity Visit 1
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Visual acuity Visit 2
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
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
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Mean spherical refraction Visit 2
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
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
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Astigmatic power J0 Visit 2
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
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
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Astigmatic power J45 Visit 2
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
Time frame: Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Contrast sensitivity Visit 1
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Contrast sensitivity Visit 2
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
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
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Rotation of IOL at visit 2
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
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
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Tilt of IOL at Visit 2
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
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
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Centration of IOL at Visit 2
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
Time frame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Fear of falling
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Fear of falling
Time frame: assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery
Fear of falling
Time frame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Risk of fall
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Risk of fall
Time frame: assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery
Risk of fall
Time frame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Cataract related quality of life
Time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery
Cataract related quality of life
Time frame: assessment at study visit 2 around 3-6 months after the first eye cataract IOL replacement surgery
Cataract related quality of life
Time frame: assessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No. no plan to share IPD
Related trials for Cataract Bilateral
Recruiting
"Comparative Study of High-frequency Pulsed Vacuum Technology Versus Phacoemulsification for Cataract Surgery
Cataract Bilateral
RecruitingPhase 4
A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
Cataract
Not yet recruitingPhase 4
Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery
Dry Eye, Dry Eye Disease (DED)
Not yet recruitingPhase 4
A Prospective, Single-Arm Clinical Evaluation of Visual, Refractive, and Patient-Reported Outcomes Following Bilateral Implantation of the TECNIS PureSee™ Extended Depth of Focus Intraocular Lens
Cataract
Not yet recruitingObservational study
Night Driving After Trifocal Versus Monofocal IOL Implantation
Cataract, Presbyopia Correction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabil Habib, MB ChB(Hons) principal investigator
Royal Eye Infirmay, University Hosptials Plymouth NHS Trust
Phillip Buckhurst, PhD study chair
University of Plymouth
Catriona MacLennan, PhD study director
Glasgow Caledonian Unviersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toric intraocular lens Zeiss AT TORBI in people with Cataract Bilateral and Astigmatism Bilateral, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherrie T Choy, MSc (07903692005, sherrie.choy@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jerk from the centre of mass Visit 1 (time frame: Baseline assessment will be carried out at study visit 1 before the cataract surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.