Condition category
Eye Diseases
Date applied
12/04/2013
Date assigned
15/05/2013
Last edited
30/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The quality of vision following cataract surgery is affected by the clarity of the ocular media (transparent substances of the eye, i.e the cornea, intraocular lens [IOL], lens capsule and vitreous gel), focus (corneal curvature and IOL) and co-morbidity, e.g. retinal or optic nerve disease. One aspect of focussing is astigmatism, where the vision is blurred due to the inability of the optics of the eye to focus a point object into a sharp focused image on the retina, and is caused in cataract post-surgical patients by asymmetry of corneal curvature. This study aims to assess the effect of two alternative means of correcting astigmatism to optimise focus. The first is the placement of additional corneal incisions to directly reduce corneal astigmatism and second is the use of toric IOLs which may alternatively be used to compensate for corneal astigmatism.

Who can participate?
Males and females aged over 18 years listed for cataract surgery.

What does the study involve?
The participants are randomly allocated to one of two groups:
Group 1: Corneal Limbal Relaxing Incisions (LRIs). These are paired partial-thickness incisions placed just within the cornea immediately prior to small incision cataract surgery. This technique corrects up to 3D of cylinder, which is the maximum level correctable on the inclusion criteria.
Group 2: IOL. The Tecnis toric IOL is implanted during cataract surgery to correct astigmatism.
The study will be conducted in compliance with the protocol, Good Clinical Practice, and all applicable regulatory requirements.

What are the possible benefits and risks of participating?
The study intervention is a choice between two alternative means of reducing post-operative astigmatism. Additional surgical incisions carry a risk of infection, reduced by the routine use of post-operative antibiotic eyedrops. The corneal incisions may also in the immediate post-operative period give a foreign body sensation in the eye. Toric IOLs may rotate in the eye; if rotation is excessive then surgical repositioning may be required. Both techniques carry the risk of over- or under-correcting astigmatism, such that spectacle correction of vision remains necessary.

Where is the study run from?
Royal Berkshire NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
The study is planned to start in May 2013 and run for 12 months.

Who is funding the study?
Abbott Medical Optics Inc. (USA).

Who is the main contact?
Mr Martin Leyland
Consultant Ophthalmologist
Eye Dept. Royal Berkshire Hospital
London Road
Reading RG1 5AN

Trial website

Contact information

Type

Scientific

Primary contact

Mr Martin Leyland

ORCID ID

Contact details

Royal Berkshire NHS Foundation Trust
London Road
Reading
RG1 5AN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13/SC/0050

Study information

Scientific title

Randomised controlled trial of Tecnis 1-piece toric intraocular lens (IOL) versus limbal relaxing incisions in the management of cataract astigmatism

Acronym

Study hypothesis

Toric IOLs may be an effective alternative to limbal relaxing incisions (LRIs) for the treatment of astigmatism post cataract surgery.

Ethics approval

Berkshire South Central NRES Committee, 05/03/2013, ref: 13/SC/0050

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cataract surgery

Intervention

Reducing astigmatism by comparing toric IOLs vs limbal relaxing incisions (LRIs). This study is a randomised controlled trial of two techniques to control post-operative astigmatism.

Group 1: Corneal Limbal Relaxing Incisions (LRIs). These are paired partial thickness incisions placed just within the cornea immediately prior to small incision cataract surgery. This technique corrects up to 3D of cylinder, which is the maximum level correctable on the inclusion criteria.

Group 2: IOL. The Tecnis toric IOL is can be implanted during cataract surgery to correct astigmatism, and is available in cylindrical powers of 1.00, 1.5, 2.25, 3.00 and 4.00 with a spherical diopter range of 5-34 dioptres. Toric IOL biometry calculations using a proprietary algorithm (AMO Abbott Medical Optical), cross-referenced with standard biometry calculation.

The study will be conducted in compliance with the protocol, Good Clinical Practice, and all applicable regulatory requirements.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Visual acuity
2. Corneal astigmatism

Unaided vision will be measured 2 weeks after the operation.
Optician sight test will be carried out 6 weeks after the operation.

Secondary outcome measures

Visual satisfaction score will be measured 6 weeks after the operation.

Overall trial start date

01/05/2013

Overall trial end date

01/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Symptomatic cataract
2. Vision 6/12 or worse
3. Corneal astigmatism >0.75D horizontal or >1.25D vertical and (maximum 3.0D)
4. Males and females aged over 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. <18 years of age
2. Astigmatism >3.0D or irregular
3. Dry eye severe enough to affect keratometry despite topical lubricant treatment
4. Ocular co-morbidity

Recruitment start date

01/05/2013

Recruitment end date

01/01/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

Royal Berkshire NHS Foundation Trust (UK)

Sponsor details

London Road
Reading
RG1 5AN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.royalberkshire.nhs.uk

Funders

Funder type

Industry

Funder name

Abbott Medical Optics Inc. (USA) will provide the toric IOL at the same price as the non-toric IOL

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes