Contact information
Type
Scientific
Primary contact
Mr Oliver Findl
ORCID ID
Contact details
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
+44 (0)20 7566 2036
oliver.findl@moorfields.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FINO1001
Study information
Scientific title
Acronym
Study hypothesis
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
Approved by Moorfields and Whittington LREC on the 15th November 2006 (ref: 06/Q0504/96).
Study design
Randomised, bilateral, double-masked clinical trial with intra-individual comparison
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cataract; posterior capsular opacification
Intervention
Intraocular lens implant (XCelens Idea or Acrysof)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
1. Anterior chamber depth (mm) with ACMaster
2. Decentration (mm)
3. Refraction
4. Rhexis size (mm^2)
5. Slitlamp biomicroscopy (descriptive)
Overall trial start date
28/11/2006
Overall trial end date
28/05/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
35 (70 eyes)
Participant exclusion criteria
Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, retinal degenerations, ocular trauma, etc.)
Recruitment start date
28/11/2006
Recruitment end date
28/05/2009
Locations
Countries of recruitment
Austria, United Kingdom
Trial participating centre
Moorfields Eye Hospital NHS Foundation Trust
London
EC1V 2PD
United Kingdom
Sponsor information
Organisation
Moorfields Eye Hospital NHS Foundation Trust (UK)
Sponsor details
162 City Road
London
EC1V 2PD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
XCelens SA (Switzerland)
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
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21907536
Publication citations
-
Results
Gangwani V, Hirnschall N, Koshy J, Crnej A, Nishi Y, Maurino V, Findl O, Posterior capsule opacification and capsular bag performance of a microincision intraocular lens., J Cataract Refract Surg, 2011, 37, 11, 1988-1992, doi: 10.1016/j.jcrs.2011.05.035.