Condition category
Eye Diseases
Date applied
12/12/2006
Date assigned
29/01/2007
Last edited
08/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mark Wilkins

ORCID ID

Contact details

Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
+44 (0)20 7566 2036
mail@markwilkins.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WILM1007

Study information

Scientific title

A prospective randomised controlled trial comparing bilateral multifocal intraocular lens implantation with monovision following cataract surgery

Acronym

Study hypothesis

Null hypothesis:
There is no difference in the percentage of patients that report that they never wear spectacles after bilateral implantation with either TECNIS ZM000 multifocal IntraOcular Lenses (IOLs) or Bausch and Lomb Akreos AO monofocal IOLs with the powers of the monofocal IOLs adjusted to give 1.5 dioptres of monovision.

Ethics approval

Moorfields and Whittington Local Research Ethics Committee, 18/10/2006, ref: 06/Q0504/82

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cataract

Intervention

Bilateral intraocular lens implant with either TECNIS ZM000 multifocal or Bausch and Lomb Akreos AO monofocal intraocular lenses.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Percentage of patients with total spectacle independence

Secondary outcome measures

1. Visual Function 14-question (VF14) questionnaire
2. Near visual acuity
3. Reading speed
4. Binolcular Logarithm of the Minimum Angle of Resolution (LogMAR) acuity
5. Binocular Pelli Robson contrast sensitivity - photopic and dark adapted
6. Procyon pupillometry
7. Forward light scatter - van den Berg forward light scatter test
8. Wavefront aberrations - Shack Hartmann aberrometry

Overall trial start date

01/02/2007

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients requiring bilateral cataract surgery with good visual potential and a full visual field in each eye
2. Age range 30 to 90 years
3. Biometry indicating IOL power requirement within the range +10 to +30D for emmetropia (0.00 to -0.50D spherical equivalent) in both eyes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

212

Participant exclusion criteria

1. Patients aiming for a refractive result other than bilateral emmetropia (0.00 to -0.50D spherical equivalant) or emmetropia in one eye and low myopia in the other, i.e., the intended monovision outcome
2. Significant co-pathology (including macular pathology, glaucoma, uveitis, corneal disease, diabetic retinopathy, previous retinal detachment surgery)
3. Keratometric astigmatism 1.5D in either eye
4. Amblyopia
5. Congenital or traumatic cataracts
6. Poor comprehension of written or spoken English
7. Inability to give informed consent
8. Mobility, tremor or postural problems causing discomfort during slit lamp examination

Recruitment start date

01/02/2007

Recruitment end date

01/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital NHS Foundation Trust
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Moorfields Eye Hospital NHS Foundation Trust (UK)

Sponsor details

162 City Road
London
EC1V 2PD
United Kingdom

Sponsor type

Government

Website

http://www.moorfields.nhs.uk/Home

Funders

Funder type

Industry

Funder name

Advanced Medical Optics (AMO) United Kingdom Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bausch & Lomb UK Ltd (UK)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24070808

Publication citations

Additional files

Editorial Notes