Contact information
Type
Scientific
Contact name
Mr Phillip Bloom
ORCID ID
Contact details
The Hillingdon Hospital
Pield Health Road
Hillingdon
UB8 3NN
United Kingdom
+44 (0)1895 238282
phillip.bloom@thh.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0388119782
Study information
Scientific title
Acronym
Study hypothesis
How effective are accommodating intraocular lens in comparison with monofocal and multifocal lens for patients having undergone cataracts removal?
Ethics approval(s)
Ethical approval for the trial was obtained from the local hospital ethics committee prior to commencement.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Cataract
Intervention
Patients underwent bilateral sequential phacoemulsification with implantation of one of the three IOL types:
1. Accommodative IOL
2. A multifocal IOL
3. A monofocal IOL (control group)
Patients were assessed at 3 and 18 months after second-eye surgery.
Intervention type
Other
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/02/2003
Overall study end date
01/02/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing cataract surgery who are:
1. Greater than 18 years old
2. Bilateral visually significant cataracts with extraction indicated
3. Informed consent
4. Ability to understand and complete TyPE questionnaire
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
69
Participant exclusion criteria
1. Macular or other pathology considered likely to limit post-operative acuity to worse than 6/9 in either eye
2. Corneal astigmatism greater than 1.5 dioptres in either eye
3. Required IOL power outside range available for multifocal IOL (16 - 24 dioptres)
Recruitment start date
01/02/2003
Recruitment end date
01/02/2004
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
The Hillingdon Hospital
Hillingdon
UB8 3NN
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Hillingdon Hospital (UK)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2008 | Yes | No |