Acri.LISA® bifocal intraocular lens (Carl Zeiss UK) versus AcrySof® IQ ReSTOR® multifocal intraocular lens

ISRCTN	ISRCTN64155646
DOI	https://doi.org/10.1186/ISRCTN64155646
Protocol serial number	MAUV1007
Sponsor	Moorfields Eye Hospital NHS Foundation Trust (UK)
Funder	Acri.Tec GMBH (Germany) - A Carl Zeiss Meditec Company

Submission date: 16/07/2010
Registration date: 06/09/2010
Last edited: 02/06/2015

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 Vincenzo Maurino
Scientific

Consultant Ophthalmic Surgeon
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom

Phone	+44 (0)20 7566 2473
Email	vincenzo.maurino@moorfields.nhs.uk

Study information

Primary study design	Interventional
Study design	Patient- and observer-masked prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of post-operative dysphotopsia and spectacles independence after bilateral multifocal intraocular lens (IOL) implantation for cataract surgery and refractive lens exchange: Acri.LISA® 366D versus AcrySof® SN6AD1 randomised clinical trial
Study objectives	Spectacle independence is a central aim in modern cataract surgery. Although bilateral monofocal intraocular lens (IOL) implantation, aiming for emmetropia (perfect vision) or low myopia (shortsightedness), leads to high levels of patient satisfaction in distance vision, spectacle dependence for reading and other near vision tasks is the usual result. With increasing demands for complete spectacle independence after cataract surgery, multifocal IOLs have been introduced widely in cataract surgery. These have resulted in less spectacle dependence for patients. However, a variable number of patients do complain of problems with glare, haloes and lights especially in the hours of darkness (dysphotopsia symptoms). Dysphotopsia symptoms may vary significantly from patient to patient. The actual incidence of dysphotopsialike symptoms after cataract surgery and multifocal IOL implantation is unknown and most likely quite underestimated. The Acri.LISA® 366D bifocal intraocular lens (IOL) features a uniform refractive/diffractive optic design to reduce halo and glare side effects associated with multifocal intraocular lens implantation. We aim to examine whether the Acri.LISA® design advantages are reflected in greater freedom from optical side effects such as dysphotopsialike symptoms and similar spectacle freedom after surgery in comparison to one of the current marketleading multifocal IOLs, the AcrySof® SN6AD1. We propose to conduct a multicentre, prospective randomised controlled trial of 188 patients requiring bilateral cataract surgery. Patients enrolled in the study will be randomised to receive either one of the lenses mentioned above, and their satisfaction with the lens (both subjective and objective) will be assessed at one visit 4 - 6 months post-operatively.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cataracts
Intervention	We plan to randomise patients who have no significant ocular copathology, and are undergoing bilateral sequential cataract surgery or bilateral sequential refractive lens exchanged to either bilateral implantation with an Acri.LISA® multifocal IOL or an AcrySof® IQ ReSTOR® multifocal IOL. Surgery: Surgery for lens removal and IOL implantation will take place as per standard procedure and will be undertaken by Consultants only. Surgery for the second eye will take place between 1 to 4 weeks after surgery for the first eye. Post-operative follow-up appointment at Moorfields Eye Hospital four months after second eye operation (both eyes, maximum 1.5 hours duration).
Intervention type	Other
Primary outcome measure(s)	The presence of dysphotopsia symptoms (absent, mild, moderate, severe). Dysphotopsia (glare/haloes/visual disturbances) will be assessed with a questionnaire. Primary and secondary outcomes to be measured 4 - 6 months post-operatively.
Key secondary outcome measure(s)	1. Autorefraction and aberrometry and pupil size measurement using the Tracey aberrometer 2. Manifest subjective refraction and spectacle corrected monocular visual acuity measurement 3. Composite scoring of unaided visual acuity; distance and near monocular photopic. Binocular photopic distance, intermediate (50 - 60 - 70 cm) and near (40 cm) visual acuity. Binocular mesopic intermediate (70 cm), distance and near (using neutral density filters NoirU23). The composite scoring system is to be developed during the trial. Visual acuities will be measured using the New ETDRS logarithmic acuity card (Precision Vision). 4. Maximum binocular reading speed at patient preferred distance (IReST) 5. Binocular Near Reading speed 6. Binocular Contrast sensitivity - Pelli-Robson under photopic/mesopic conditions 7. Forward light scatter (C-quant) 8. Spectacle dependence questionnaire 9. Visual satisfaction questionnaire 10. Quality-of-life questionnaire (QIRC score) 11. Visual disability questionnaire - Catquest-9SF patient outcome questionnaire 12. Intra and postoperative complications 13. Slit lamp findings (dilated pupil): IOL centration 14. Adverse event recording (email and CRF) Primary and secondary outcomes to be measured 4 - 6 months post-operatively.
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	188
Key inclusion criteria	1. Patients undergoing sequential bilateral cataract surgery or refractive lens exchange 2. Patients that want to be spectacle independent 3. Male or female, aged 21 years and above
Key exclusion criteria	1. Any significant ocular co-morbidity (amblyopia, age-related macular degeneration [ARMD], glaucoma, etc) precluding post-operative visual acuity (VA) of 20/30 or better or poor zonular/capsular stability (e.g. after trauma/severe pseudoxanthoma elasticum [PXE]) 2. Corneal astigmatism more than 1.50 D on IOLMaster keratometry. Corneal astigmatism between 1.00 - 1.50 D will be reduced using standardised limbal relaxing incisions (LRI). 3. IOLMaster biometry not possible 4. IOL power less than 10D or greater than 30D 5. Professional night drivers, pilots, and other occupations for which induced dysphotopsia may be career threatening 6. Patients with severe psychiatric disorders 7. Vulnerable groups 8. Poor mobility 9. Poor comprehension of written English
Date of first enrolment	01/09/2010
Date of final enrolment	01/09/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Moorfields Eye Hospital NHS Foundation Trust

London
EC1V 2PD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/04/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes