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Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision

Sponsored by Guy's and St Thomas' NHS Foundation Trust

About this trial

Last updated 3 years ago

Study ID

311123

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 100 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Bilateral cataract requiring surgical intervention,

- age over 18 years

- able to understand informed consent and the objectives of the trial,

- not pregnant, not breast feeding

- no previous intraocular eye surgery

- good visual potential in both eyes

- corneal astigmatism of 1.5 to 6 dioptres

No

Exclusion Criteria

- Any patient with other ocular condition that might reduce visual acuity and hence confound the results such as:

- visually impairing age-related macular degeneration

- Advanced glaucoma

- previous retinal vascular disorders

- previous retinal detachment or tear

- any visually impairing neuro-ophthalmological condition

- any inherited retinal disorder or pathology

- previous strabismus surgery or record of amblyopia

- previous visually impairing CVA, TIA or other vaso-occlusive disease

- already enrolled in another study or trial

- instability of keratometry or biometry measurements

- irregular astigmatism

- previous significant trauma to eye

Locations

Location

Status