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
FINO1002
Study information
Scientific title
Effect of a plate haptic design on IntraOcular Lens rotational-and-axial stability and posterior capsule opacification: a randomised trial (Acrismart versus Acrilyc IntraOcular Lenses)
Acronym
Study hypothesis
Is the evaluation of the rotational stability (of importance for toric models), the axial stability (of importance regarding postoperative refractive outcome and refractive surprises) and the development of posterior capsular opacification of a modern MicroIncision Cataract Surgery (MICS)-compatible single-piece IntraOcular Lens (IOL) (Acri.Smart 46S) which is CE-marked and commercially available (since 2004) compared to that of an open-loop three-piece model made of the same optic material (AcriLyc 53N). Both IOL models have sharp optic edges.
Ethics approval
Moorfields and Whittington LREC on the 15th November 2006 (ref: 06/Q0504/97).
Study design
Randomised, bilateral, double-masked clinical trial with intra-individual comparison at two centres (Moorfields Eye Hospital [MEH] and Vienna)
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 (Acrismart or Acrylic lens)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Posterior capsule opacification (%)
Secondary outcome measures
1. Orientation (degrees)
2. Anterior Chamber Depth (ACD) (mm)
3. Decentration (mm)
4. Refraction
5. Rhexis size (mm^2)
6. Slitlamp biomicroscopy (descriptive)
Overall trial start date
28/11/2006
Overall trial end date
28/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Bilateral age-related cataract
2. Age 40 and older
3. Visual Acuity more than 0.05
4. Written informed consent to surgery and participation in the study
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
25 patients (50 eyes)
Participant exclusion criteria
Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, traumatic cataract and other comorbidity that could affect Posterior Capsule Opacification (PCO) rate, axial and rotational stability (e.g. Marfan syndrome)
Recruitment start date
28/11/2006
Recruitment end date
28/05/2010
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
Acri.tec AG (Germany)
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
2013 results: http://www.ncbi.nlm.nih.gov/pubmed/24064942