Validation of the BESSt Formula in eyes undergoing phacoemulsification following keratorefractive surgery
| ISRCTN | ISRCTN34442493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34442493 |
| Protocol serial number | N0141187716 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Moorfields Eye Hospital NHS Foundation Trust, NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Centrally randomised controlled trial - pilot study |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Patient recruitment rates |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| 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
- United Kingdom
- England
Study participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
