Validation of the BESSt Formula in eyes undergoing phacoemulsification following keratorefractive surgery
| ISRCTN | ISRCTN34442493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34442493 |
| Secondary identifying numbers | N0141187716 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 13/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Edmondo Borasio
Scientific
Scientific
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
| edmondoborasio@gmail.com |
Study information
| Study design | Centrally randomised controlled trial - pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Cataract |
| Intervention | 1. BESSt© 2. Hollday |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/08/2006 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 30 eyes |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Moorfields Eye Hospital NHS Foundation Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2006 | Yes | No |
