Vision and Balance Changes After Bilateral Implantation of Toric IOLs

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

Interventions

DEVICE

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.

Sponsors & Collaborators

• Carl Zeiss Meditec AG

  collaborator INDUSTRY

• Glasgow Caledonian University

  collaborator OTHER

• University of St Mark and St John Plymouth

  collaborator UNKNOWN

• University Hospital Plymouth NHS Trust

  collaborator OTHER

• University of Plymouth

  lead OTHER

Principal Investigators

• Nabil Habib, MB ChB(Hons) · Royal Eye Infirmay, University Hosptials Plymouth NHS Trust

• Phillip Buckhurst, PhD · University of Plymouth

• Catriona MacLennan, PhD · Glasgow Caledonian Unviersity

• Gary L.K. Shum, PhD · Plymouth Marjon University

• Hetal Buckhurst, PhD · University of Plymouth

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-12

Primary Completion

2024-12-30

Completion

2025-07-31

Countries

• United Kingdom

Study Locations