Axial IntraOcular Lens position and posterior capsule opacification with a microincisional single-piece open-loop hydrophilic IntraOcular Lens: a randomised trial (XCelens Idea versus single-piece Acrysof IntraOcular Lens)

ISRCTN	ISRCTN88407981
DOI	https://doi.org/10.1186/ISRCTN88407981
Protocol serial number	FINO1001
Sponsor	Moorfields Eye Hospital NHS Foundation Trust (UK)
Funder	XCelens SA (Switzerland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Oliver Findl
Scientific

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

Phone	+44 (0)20 7566 2036
Email	oliver.findl@moorfields.nhs.uk

Primary study design	Interventional
Study design	Randomised, bilateral, double-masked clinical trial with intra-individual comparison
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To assess the axial stability and the Posterior Capsule Opacification (PCO) inhibiting efficacy of a 360° sharp edge hydrophilic IntraOcular Lens (IOL) (Idea, XCelens) and compare it to that of a standard hydrophobic acrylic IOL (Acrysof SA60AT, Alcon) both single-piece open-loop in design with sharp optic edges.
Ethics approval(s)	Approved by Moorfields and Whittington LREC on the 15th November 2006 (ref: 06/Q0504/96).
Health condition(s) or problem(s) studied	Cataract; posterior capsular opacification
Intervention	Intraocular lens implant (XCelens Idea or Acrysof)
Intervention type	Other
Primary outcome measure(s)	Posterior Capsule Opacification (PCO), measured with an image analysis system Automated QUantification of After-cataract (AQUA), scale zero to ten, from digital retroillumination photographs of the posterior capsule at two years.
Key secondary outcome measure(s)	1. Anterior chamber depth (mm) with ACMaster 2. Decentration (mm) 3. Refraction 4. Rhexis size (mm^2) 5. Slitlamp biomicroscopy (descriptive)
Completion date	28/05/2009

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	35
Key inclusion criteria	1. Bilateral age-related cataract 2. Age 40 and older 3. Visual Acuity more than 0.05 4. Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant 5. Written informed consent to surgery and participation in the study
Key exclusion criteria	Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, retinal degenerations, ocular trauma, etc.)
Date of first enrolment	28/11/2006
Date of final enrolment	28/05/2009

Moorfields Eye Hospital NHS Foundation Trust

London
EC1V 2PD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2011		Yes	No