Condition category
Eye Diseases
Date applied
12/12/2006
Date assigned
29/01/2007
Last edited
29/06/2016
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

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

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

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

Publication citations

Additional files

Editorial Notes

29/06/2016: Publication reference added