Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision

Summary

In an aging population, cataract and presbyopia become increasingly common. A cataract is the opacification of the natural crystalline lens inside a person's eye, causing reduction of vision. Presbyopia is an age related condition resulting in loss of reading/near vision which results in requiring reading glasses.

Astigmatism is a common condition characterized by an abnormal cornea (the clear tissue at the front of the eye) which results in blurred distance and near vision, again requiring glasses.

Cataract surgery is the most common elective surgery worldwide for patients over 65. It is composed of removal the cataract and insertion of a new intraocular lens (IOL). Currently only monofocal IOLs are available on the National Health Service (United Kingdom) - meaning they give good distance or near vision. The majority of patients opt for good distance vision with glasses to read.

The investigators are trialling insertion of a new Extended Depth of Focus (enhanced aspheric) Toric IOL (EDoF Toric IOL), which treats all 3 conditions - cataract, presbyopia and astigmatism. All patients attending St Thomas' hospital for treatment of cataracts, who have presbyopia and astigmatism will be considered for invitation to the study.

Patients who participate in the study will be randomly selected to receive either the new IOL - the TECNIS Eyhance Toric II IOL, or a well-established IOL the Alcon Acrysof IQ Toric IOL during cataract surgery. Insertion of the Alcon Acrysof IQ Toric IOL is known to treat cataract and astigmatism but not presbyopia.

Patients will be assessed and have their surgery performed at St Thomas' Hospital London. They will have 7 appointments over 12 months, plus surgery. The investigators hope to demonstrate better distance, intermediate and near vision and increased spectacle independence in the TECNIS Eyhance Toric II IOL group.

EDoF Toric IOLs have the potential to transform cataract surgery outcomes for patients in the NHS.

Conditions

• Cataract
• Presbyopia
• Astigmatism

Interventions

DEVICE

Intervention arm - Eyhance Toric II Intraocular Lens

Bilateral cataract extraction and insertion of Eyhance Toric II Intraocular Lens

DEVICE

Control Arm - Alcon IQ Toric Intraocular lens

Bilateral cataract extraction and insertion of Alcon IQ Toric Intraocular Lens

Sponsors & Collaborators

• City, University of London

  collaborator OTHER

• King's College London

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• David O'Brart, MBBS, MD · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-30

Primary Completion

2024-09-30

Completion

2024-09-30

FDA Device

Yes

Countries

• United Kingdom

Study Locations