| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN41218609 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0141187713 |
| Public title | The effect of cataract surgical techniques on the corneal endothelium: a comparison between conventional phacoemulsification with Aqualase |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Cataract |
| Study hypothesis | To compare two techniques of cataract surgery: conventional phacoemulsification versus the newer Aqualase technique especially looking at the rate of corneal endothelial cell loss and complications rate seen with each technique. |
| Design/methodology | Randomised controlled pilot study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Routine cataracts less than or equal to grade 3 determined by Oxford grading scale |
| Participants - exclusion criteria | 1. Other ocular or systemic co-morbidity factors
2. Patients with an axial length greater than 26.5mm
3. Combined procedures
4. Cataracts greater than grade 3 |
| Patient information material |
|
| Anticipated start date | 20/09/2006 |
| Anticipated end date | 20/12/2006 |
| Status of trial | Completed |
| Target number of participants | 30 patients - 30 eyes in each group |
| Interventions | 1. Standard phacoemulsification
2. Aqualase |
| Primary outcome measure(s) | Percentage of cell loss |
| Secondary outcome measure(s) | 1. Coefficient of variation and hexagonality of cell sizes at 3 months
2. Per-and-postoperative complications |
| 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 Scott Hau |
| Contact details | Moorfields Eye Hospital
162 City Road
London
United Kingdom
EC1V 2PD |
| Contact telephone | +44 |
| Contact fax | +44 |
| Contact email | Scott.Hau@moorfields.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN41218609 |
| Date last extracted from ISRCTN register | 17/04/2008 |
