| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN34442493 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0141187716 |
| Public title | Validation of the BESSt Formula in eyes undergoing phacoemulsification following keratorefractive surgery |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Cataract |
| 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. |
| Design/methodology | Centrally randomised controlled trial - pilot study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/08/2006 |
| Anticipated end date | 01/05/2007 |
| Status of trial | Completed |
| Target number of participants | 30 eyes |
| Interventions | 1. BESSt©
2. Hollday |
| Primary outcome measure(s) | 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 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 |
| Sources of funding | Moorfields Eye Hospital NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Edmondo Borasio |
| Contact details | Moorfields Eye Hospital
162 City Road
London
United Kingdom
EC1V 2PD |
| Contact telephone | +44 |
| Contact fax | +44 |
| Contact email | edmondoborasio@gmail.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN34442493 |
| Date last extracted from ISRCTN register | 17/04/2008 |
