The effect of cataract surgical techniques on the corneal endothelium: a comparison between conventional phacoemulsification with Aqualase
| ISRCTN | ISRCTN41218609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41218609 |
| Protocol serial number | N0141187713 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Moorfields Eye Hospital NHS Foundation Trust (UK) NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 29/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Scott Hau
Scientific
Scientific
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
| Phone | +44 |
|---|---|
| Scott.Hau@moorfields.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled pilot study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Cataract |
| Intervention | 1. Standard phacoemulsification 2. Aqualase |
| Intervention type | Other |
| Primary outcome measure(s) |
Percentage of cell loss |
| Key secondary outcome measure(s) |
1. Coefficient of variation and hexagonality of cell sizes at 3 months |
| Completion date | 20/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | Routine cataracts less than or equal to grade 3 determined by Oxford grading scale |
| Key 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 |
| Date of first enrolment | 20/09/2006 |
| Date of final enrolment | 20/12/2006 |
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 |