Contact information
Type
Scientific
Primary contact
Mr Scott Hau
ORCID ID
Contact details
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
+44
Scott.Hau@moorfields.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0141187713
Study information
Scientific title
Acronym
Study hypothesis
To compare two techniques of cataract surgery: conventional phacoemulsification versus the newer Aqualase technique especially looking at the rate of corneal endothelial cell loss and complications rate seen with each technique.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Eye Diseases: Cataract
Intervention
1. Standard phacoemulsification
2. Aqualase
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Percentage of cell loss
Secondary outcome measures
1. Coefficient of variation and hexagonality of cell sizes at 3 months
2. Per-and-postoperative complications
Overall trial start date
20/09/2006
Overall trial end date
20/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Routine cataracts less than or equal to grade 3 determined by Oxford grading scale
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30 patients - 30 eyes in each group
Participant exclusion criteria
1. Other ocular or systemic co-morbidity factors
2. Patients with an axial length greater than 26.5mm
3. Combined procedures
4. Cataracts greater than grade 3
Recruitment start date
20/09/2006
Recruitment end date
20/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Moorfields Eye Hospital NHS Foundation Trust (UK) NHS R&D Support Funding
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
Basic results (scientific)
Publication list
No publication intended as of 29/09/2011