Additional identifiers
EudraCT 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Eye Diseases: Cataract
Intervention
1. Aqualase
2. Phacoemulsification
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Corneal endothelial cell counts and coefficient of variation of cell size
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2005
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients who have requested removal of soft to moderately dense cataracts.
Participant type
Patient
Age group
Not Specified
Gender
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
United Kingdom
Trial 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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18499007
Publication citations
-
Results
Barsam A, Chandra A, Bunce C, Whitefield LA, Prospective randomized controlled trial to compare the effect on the macula of AquaLase liquefaction and ultrasound phacoemulsification cataract surgery., J Cataract Refract Surg, 2008, 34, 6, 991-995, doi: 10.1016/j.jcrs.2008.02.017.