A prospective randomised controlled trial comparing bilateral multifocal intraocular lens implantation with monovision following cataract surgery
| ISRCTN | ISRCTN37400841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37400841 |
| Protocol serial number | WILM1007 |
| Sponsor | Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Funders | Advanced Medical Optics (AMO) United Kingdom Ltd (UK), Bausch & Lomb UK Ltd (UK) |
- Submission date
- 12/12/2006
- Registration date
- 29/01/2007
- Last edited
- 08/04/2015
- 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 Mark Wilkins
Scientific
Scientific
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
| Phone | +44 (0)20 7566 2036 |
|---|---|
| mail@markwilkins.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective randomised controlled trial comparing bilateral multifocal intraocular lens implantation with monovision following cataract surgery |
| Study objectives | Null hypothesis: There is no difference in the percentage of patients that report that they never wear spectacles after bilateral implantation with either TECNIS ZM000 multifocal IntraOcular Lenses (IOLs) or Bausch and Lomb Akreos AO monofocal IOLs with the powers of the monofocal IOLs adjusted to give 1.5 dioptres of monovision. |
| Ethics approval(s) | Moorfields and Whittington Local Research Ethics Committee, 18/10/2006, ref: 06/Q0504/82 |
| Health condition(s) or problem(s) studied | Cataract |
| Intervention | Bilateral intraocular lens implant with either TECNIS ZM000 multifocal or Bausch and Lomb Akreos AO monofocal intraocular lenses. |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Percentage of patients with total spectacle independence |
| Key secondary outcome measure(s) |
1. Visual Function 14-question (VF14) questionnaire |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 212 |
| Key inclusion criteria | 1. Patients requiring bilateral cataract surgery with good visual potential and a full visual field in each eye 2. Age range 30 to 90 years 3. Biometry indicating IOL power requirement within the range +10 to +30D for emmetropia (0.00 to -0.50D spherical equivalent) in both eyes |
| Key exclusion criteria | 1. Patients aiming for a refractive result other than bilateral emmetropia (0.00 to -0.50D spherical equivalant) or emmetropia in one eye and low myopia in the other, i.e., the intended monovision outcome 2. Significant co-pathology (including macular pathology, glaucoma, uveitis, corneal disease, diabetic retinopathy, previous retinal detachment surgery) 3. Keratometric astigmatism 1.5D in either eye 4. Amblyopia 5. Congenital or traumatic cataracts 6. Poor comprehension of written or spoken English 7. Inability to give informed consent 8. Mobility, tremor or postural problems causing discomfort during slit lamp examination |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Moorfields Eye Hospital NHS Foundation Trust
London
EC1V 2PD
United Kingdom
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 | 01/12/2013 | Yes | No |
