Condition category
Eye Diseases
Date applied
16/07/2010
Date assigned
06/09/2010
Last edited
02/06/2015
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 Vincenzo Maurino

ORCID ID

Contact details

Consultant Ophthalmic Surgeon
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
+44 (0)20 7566 2473
vincenzo.maurino@moorfields.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MAUV1007

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Patient- and observer-masked prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/09/2010

Overall trial end date

01/09/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

188

Participant 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

Recruitment start date

01/09/2010

Recruitment end date

01/09/2012

Locations

Countries of recruitment

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

c/o Ms Suzanne Cabral
Research and Development Department
162 City Road
London
EC1V 2PD
United Kingdom

Sponsor type

Government

Website

http://www.moorfields.nhs.uk

Funders

Funder type

Industry

Funder name

Acri.Tec GMBH (Germany) - A Carl Zeiss Meditec Company

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25537197

Publication citations

Additional files

Editorial Notes