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
Secondary identifying numbers FINO1001
Submission date
12/12/2006
Registration date
29/01/2007
Last edited
12/11/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised, bilateral, double-masked clinical trial with intra-individual comparison
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedCataract; posterior capsular opacification
InterventionIntraocular lens implant (XCelens Idea or Acrysof)
Intervention typeOther
Primary outcome measurePosterior 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.
Secondary outcome measures1. Anterior chamber depth (mm) with ACMaster
2. Decentration (mm)
3. Refraction
4. Rhexis size (mm^2)
5. Slitlamp biomicroscopy (descriptive)
Overall study start date28/11/2006
Completion date28/05/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants35 (70 eyes)
Key inclusion criteria1. 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 criteriaRelevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, retinal degenerations, ocular trauma, etc.)
Date of first enrolment28/11/2006
Date of final enrolment28/05/2009

Locations

Countries of recruitment

  • Austria
  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

162 City Road
London
EC1V 2PD
England
United Kingdom

Website http://www.moorfields.nhs.uk/Home
ROR logo "ROR" https://ror.org/03zaddr67

Funders

Funder type

Industry

XCelens SA (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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