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)

ISRCTN	ISRCTN01285948
DOI	https://doi.org/10.1186/ISRCTN01285948
Secondary identifying numbers	FINO1002

Submission date: 12/12/2006
Registration date: 29/01/2007
Last edited: 29/06/2016

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 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
Study setting(s)	Hospital
Study type	Treatment
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)
Study objectives	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(s)	Moorfields and Whittington LREC on the 15th November 2006 (ref: 06/Q0504/97).
Health condition(s) or problem(s) studied	Cataract; posterior capsular opacification
Intervention	Intraocular lens implant (Acrismart or Acrylic lens)
Intervention type	Other
Primary outcome measure	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 study start date	28/11/2006
Completion date	28/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	25 patients (50 eyes)
Key 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
Key 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)
Date of first enrolment	28/11/2006
Date of final enrolment	28/05/2010

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"	https://ror.org/03zaddr67

Funders

Funder type

Industry

Acri.tec AG (Germany)

No information available

Results and Publications

Intention to publish date
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?
Results article	results:	01/12/2013		Yes	No

Editorial Notes

29/06/2016: Publication reference added