Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0533171160
Study information
Scientific title
Acronym
Study hypothesis
To determine any potential difference in effect on corneal endothelial cell loss between two methods for removing cataracts: aqualase and phacoemulsification.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
Eye Diseases: Cataract
Intervention
1. Aqualase
2. Phacoemulsification
Intervention type
Other
Primary outcome measure
Corneal endothelial cell counts and coefficient of variation of cell size
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/10/2005
Overall study end date
01/10/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who have requested removal of soft to moderately dense cataracts.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Ocular co-morbidity resulting in anterior segment pathology
2. Previous intra-ocular inflammation
3. Raised intra-ocular pressure
4. Previous intra-ocular surgery
Recruitment start date
01/10/2005
Recruitment end date
01/10/2006
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 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
Queen Mary's Sidcup NHS Trust (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 |