Comparison of the effect of Aqualase and Phacoemulsification Cataract Surgery on Corneal Endothelium
| ISRCTN | ISRCTN57578476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57578476 |
| Protocol serial number | N0533171160 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Queen Mary's Sidcup NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Corneal endothelial cell counts and coefficient of variation of cell size |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
DA14 6LT
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 | 01/06/2008 | Yes | No |
