Contact information
Type
Scientific
Primary contact
Dr Edmondo Borasio
ORCID ID
Contact details
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
edmondoborasio@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0141187716
Study information
Scientific title
Acronym
Study hypothesis
To assess the feasibility of a randomised controlled trial to assess the accuracy of a formula (BESSt© formula) recently developed to calculate the power of the lens to implant in the eye during cataract surgery in eyes which have previously undergone laser refractive surgery.
Ethics approval
Not provided at time of registration
Study design
Centrally randomised controlled trial - 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. BESSt©
2. Hollday
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Patient recruitment rates
2. Rates of loss to follow up in treatment arm
3. Difference between target and achieved manifest refraction following phaci in the two groups
Secondary outcome measures
Proportion of eyes with outcomes within +0.25/0.5/0.75/1/1.50/2.0D from the target refraction using the different formulae
Overall trial start date
01/08/2006
Overall trial end date
01/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Any eye undergoing phaco following keratorefractive surgery
2. Any intraocular lens (IOL) model
3. Any type of keratorefractive surgery
4. Patients under the care of Ms Ficker or Mr Stevens
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30 eyes
Participant exclusion criteria
1. Children
2. Corneal scarring or opacity
3. Severe dry eyes or ptosis
4. Complicated phaco, presence of a rhexis tear if IOL is implanted in bag
Recruitment start date
01/08/2006
Recruitment end date
01/05/2007
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
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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
Results - basic reporting
Publication summary
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/17137976
Publication citations
-
Results
Borasio E, Stevens J, Smith GT, Estimation of true corneal power after keratorefractive surgery in eyes requiring cataract surgery: BESSt formula., J Cataract Refract Surg, 2006, 32, 12, 2004-2014, doi: 10.1016/j.jcrs.2006.08.037.