Acri.LISA® bifocal intraocular lens (Carl Zeiss UK) versus AcrySof® IQ ReSTOR® multifocal intraocular lens
| ISRCTN | ISRCTN64155646 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64155646 |
| Secondary identifying numbers | MAUV1007 |
- 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
Not provided at time of registration
Contact information
Mr Vincenzo Maurino
Scientific
Scientific
Consultant Ophthalmic Surgeon
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
| Phone | +44 (0)20 7566 2473 |
|---|---|
| vincenzo.maurino@moorfields.nhs.uk |
Study information
| Study design | Patient- and observer-masked prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 01/09/2010 |
| Overall study end date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 188 |
| 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 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
- England
- United Kingdom
Study participating centre
Moorfields Eye Hospital NHS Foundation Trust
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Ms Suzanne Cabral
Research and Development Department
162 City Road
London
EC1V 2PD
England
United Kingdom
| Website | http://www.moorfields.nhs.uk |
|---|---|
"ROR" |
https://ror.org/03zaddr67 |
Funders
Funder type
Industry
Acri.Tec GMBH (Germany) - A Carl Zeiss Meditec Company
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 | 01/04/2015 | Yes | No |
