Comparison of the effect of Aqualase and Phacoemulsification Cataract Surgery on Corneal Endothelium
| ISRCTN | ISRCTN57578476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57578476 |
| Secondary identifying numbers | N0533171160 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 11/05/2009
- 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
Mr Laurence Whitefield
Scientific
Scientific
Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To determine any potential difference in effect on corneal endothelial cell loss between two methods for removing cataracts: aqualase and phacoemulsification. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Cataract |
| Intervention | 1. Aqualase 2. Phacoemulsification |
| Intervention type | Other |
| Primary outcome measure | Corneal endothelial cell counts and coefficient of variation of cell size |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2005 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key inclusion criteria | Patients who have requested removal of soft to moderately dense cataracts. |
| Key exclusion criteria | 1. Ocular co-morbidity resulting in anterior segment pathology 2. Previous intra-ocular inflammation 3. Raised intra-ocular pressure 4. Previous intra-ocular surgery |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
DA14 6LT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 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
Queen Mary's Sidcup NHS Trust (UK)
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 | 01/06/2008 | Yes | No |
