Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/04/2015
Prospective/Retrospective
Retrospectively 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 Martin Leyland

ORCID ID

Contact details

Eye Department
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0199136008

Study information

Scientific title

Quality of Vision with the Acrysof Natural Intraocular Lens

Acronym

Study hypothesis

Does the new Acrysof Natural Intraocular Lens, which reduces the amount of damaging blue light reaching the retina, have any significant effect on visual outcome or colour vision post cataract surgery?

Ethics approval

Not provided at time of registration

Study design

Randomised prospective single-centre surgical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Cataract

Intervention

Randomised, prospective single centre surgical study to determine whether the new Acrysof Natural Intraocular Lens has any significant effect on visual outcome or colour vision post cataract surgery

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Colour vision
2. Visual acuity
3. Contrast sensitivity

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/12/2003

Overall trial end date

28/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

20 patients and 20 controls having standard cataract surgery

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/12/2003

Recruitment end date

28/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Berkshire and Battle Hospitals NHS Trust (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

Publication citations

Additional files

Editorial Notes