Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
09/09/2016
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 Paul G Ursell

ORCID ID

Contact details

The Roy Harfitt Eye Unit
Sutton Hospital
Cotswold Road
Sutton
Surrey
SM2 5LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0112146488

Study information

Scientific title

Prospective randomised trial of the surface cytology of 3 different single piece acrylic intraocular lenses (IOL)

Acronym

Study hypothesis

The aim of this study is to assess the biocompatibility of the most commonly used IOL Acrysof with two new acrylic IOLs recently approved for use in the UK, Centreflex and Akreso-fit.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

No participant information sheet available

Condition

Surgery: Eye

Intervention

IOL Acrysof vs two new acrylic IOLs recently approved for use in the UK, Centreflex and Akreso-fit

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Understanding the biocompatibility of these IOLs will enable surgeons to ascertain whether these IOLs are safe for use in all cases, and also whether there are any unexpected complications that may arise on extended analysis such as this.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/10/2002

Overall trial end date

01/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who are undergoing routine cataract surgery without pre-existing ocular of systemic disease.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Pre-existing ocular or systematic disease which may interfere with their post-operative inflammatory course, including diabetic retinopathy, glaucoma, uveitis, pseudoexfloiation, previous eye surgery, contralateral surgery in the previous 4 months, extremes of age (<60, >90 years), significant macular degeneration or amblyopia precluding a post-operative vision of >6/12, mature cataracts requiring Visual Blue for extraction.

Recruitment start date

31/10/2002

Recruitment end date

01/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Roy Harfitt Eye Unit
Sutton, Surrey
SM2 5LT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Epsom and St Helier University Hospitals NHS Trust (UK) NHS R&D Support Funding

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

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.