Vision and Balance Changes After Bilateral Implantation of Toric IOLs
NCT ID: NCT05629078
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2024-01-12
2025-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Toric Intraocular lens
Toric intraocular lens- AT TORBI® 709M, to be implanted bilaterally in the cataract surgery to correct astigmatism at the same time.
Toric intraocular lens Zeiss AT TORBI
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.
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.
Toric intraocular lens Zeiss AT TORBI
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.
Interventions
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Toric intraocular lens Zeiss AT TORBI
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* on waiting list for bilateral cataract surgery in NHS
Exclusion Criteria
* 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
50 Years
75 Years
ALL
No
Sponsors
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Carl Zeiss Meditec AG
INDUSTRY
Glasgow Caledonian University
OTHER
University of St Mark and St John Plymouth
UNKNOWN
University Hospital Plymouth NHS Trust
OTHER
University of Plymouth
OTHER
Responsible Party
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Dr Phillip J Buckhurst
Professor
Principal Investigators
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Nabil Habib, MB ChB(Hons)
Role: PRINCIPAL_INVESTIGATOR
Royal Eye Infirmay, University Hosptials Plymouth NHS Trust
Phillip Buckhurst, PhD
Role: STUDY_CHAIR
University of Plymouth
Catriona MacLennan, PhD
Role: STUDY_DIRECTOR
Glasgow Caledonian Unviersity
Gary L.K. Shum, PhD
Role: STUDY_DIRECTOR
Plymouth Marjon University
Hetal Buckhurst, PhD
Role: STUDY_DIRECTOR
University of Plymouth
Locations
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Royal Eye Infirmary
Plymouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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286913
Identifier Type: -
Identifier Source: org_study_id
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