Condition category
Eye Diseases
Date applied
12/12/2006
Date assigned
29/01/2007
Last edited
12/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.moorfields.nhs.uk/Home

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

  1. 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.

Additional files

Editorial Notes