Pupil dilation prior to cataract surgery with a pledget sponge - a randomised controlled trial.
| ISRCTN | ISRCTN63768137 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63768137 |
| Protocol serial number | N0280141214 |
| Sponsor | Department of Health |
| Funders | Wirral Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 23/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Austin McCormick
Scientific
Scientific
Department of Opthamology
Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Is pledget sponge soaked in dilating drops as effective as simple repeated drop administration in producing pupil dilation? |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Surgery: Cataract |
| Intervention | Randomised controlled trial. 1. Pledget sponge. 2. Repeated drop administration. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | tropicamide phenylepherine atropine |
| Primary outcome measure(s) |
Pupil diameter |
| Key secondary outcome measure(s) |
Pain or discomfort on administration of drops or pledget assessed using a visual analogue scale |
| Completion date | 01/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | Plan for 40 patients per group, on average 6 patients per list means approximately 14 lists, 2 Lists per week over 7 weeks. |
| Key exclusion criteria | Previous eye disease likely to cause a small pupil |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/08/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Opthamology
Wirral
CH49 5PE
United Kingdom
CH49 5PE
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 | 01/08/2006 | Yes | No |
