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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list