Vision and Balance Changes After Bilateral Implantation of Toric IOLs

NCT05629078 | Recruiting

• 1 other identifier: 286913
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Bilateral; Astigmatism Bilateral

Keywords

toric intraocular lens; dynamic stability; balance; post-cataract surgery; fear of falling; visual function; quality of life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (36)

• Unaided vision Visit 1

  Baseline assessment will be carried out at study visit 1 before the cataract surgery

• Unaided visionVisit 2

  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

  Final reassessment at study visit 3 around 3-6 months after the second eye cataract IOL replacement surgery

• Visual acuity Visit 1

  Baseline assessment will be carried out at study visit 1 before the cataract surgery

• Visual acuity Visit 2

  First reassessment will be carried out at study visit 2 around 3-6 months after the first cataract IOL replacement surgery

Study Arms (2)

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.

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.

Device: Toric intraocular lens Zeiss AT TORBI

Interventions

Toric intraocular lens Zeiss AT TORBI DEVICE

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.

Also known as: Monofocal non-toric intraocular lens Zeiss CT ASPHINA 409/509M

Monofocal intraocular lens; Toric Intraocular lens

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral significant corneal astigmatism \>1.0D
• on waiting list for bilateral cataract surgery in NHS

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Plymouth: lead
• Carl Zeiss Meditec AG: collaborator
• Glasgow Caledonian University: collaborator
• University of St Mark and St John Plymouth: collaborator
• University Hospital Plymouth NHS Trust: collaborator

Study Sites (1)

Royal Eye Infirmary

Plymouth, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Nabil Habib, MB ChB(Hons)

  Royal Eye Infirmay, University Hosptials Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

• Phillip Buckhurst, PhD

  University of Plymouth

  STUDY CHAIR

• Catriona MacLennan, PhD

  Glasgow Caledonian Unviersity

  STUDY DIRECTOR

• Gary L.K. Shum, PhD

  Plymouth Marjon University

  STUDY DIRECTOR

• Hetal Buckhurst, PhD

  University of Plymouth

  STUDY DIRECTOR

Central Study Contacts

Sherrie T Choy, MSc

CONTACT

07903692005; sherrie.choy@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: investigators will be blinded to which types of IOLs implanted to the cataract patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomised control trial

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: November 29, 2022
• Study Start: January 12, 2024
• Primary Completion: December 30, 2024
• Study Completion: July 31, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)