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

ISRCTN	ISRCTN64865132
DOI	https://doi.org/10.1186/ISRCTN64865132
Secondary identifying numbers	N0112146488

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Paul G Ursell
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	No participant information sheet available
Scientific title	Prospective randomised trial of the surface cytology of 3 different single piece acrylic intraocular lenses (IOL)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	31/10/2002
Completion date	01/02/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients who are undergoing routine cataract surgery without pre-existing ocular of systemic disease.
Key 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.
Date of first enrolment	31/10/2002
Date of final enrolment	01/02/2006

The Roy Harfitt Eye Unit

Sutton, Surrey
SM2 5LT
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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