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 |
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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
Scientific
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
Phone | +44 (0)20 7566 2036 |
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oliver.findl@moorfields.nhs.uk |
Study information
Study design | Randomised, bilateral, double-masked clinical trial with intra-individual comparison |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 28/11/2006 |
Completion date | 28/05/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 35 (70 eyes) |
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 |
Locations
Countries of recruitment
- Austria
- England
- United Kingdom
Study participating centre
Moorfields Eye Hospital NHS Foundation Trust
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
162 City Road
London
EC1V 2PD
England
United Kingdom
Website | http://www.moorfields.nhs.uk/Home |
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https://ror.org/03zaddr67 |
Funders
Funder type
Industry
XCelens SA (Switzerland)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/11/2011 | Yes | No |