To determine whether an eye shield is necessary following uncomplicated phacoemulsification cataract surgery
| ISRCTN | ISRCTN27712572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27712572 |
| Protocol serial number | N0084125075 |
| Sponsor | Department of Health |
| Funder | The North and South Bank Research and Development Consortium (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 25/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 J Innes
Scientific
Scientific
Hull Royal Infirmary
Ophthalmology Unit
Hull
HU3 2JZ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised case controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | To determine whether an eye shield is necessary following uncomplicated phacoemulsification cataract surgery |
| Study objectives | To determine whether there are increased post-operative complications in patients using an eye shield. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Cataract |
| Intervention | The study group will be 75 patients with uncomplicated phacoemulsification in whom an eye shield will be used in the postop period over the operated eye. The shield will be used at night for a period of 1 week. The control group will comprise 75 patients with uncomplicated phacoemulsification with no eye shield for use in the postoperative period. A similar operative technique will be employed for each patient selected for this study. As far as possible the same anaesthetic technique will be used for each patient. Patients with coexisting or previous ocular pathology other than cataract will not be included. Following surgery patients will be randomised to one of the two groups. Information will be gathered by standardised questionnaire administered by ophthalmic nursing staff one week after surgery during their routine post operative visit. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Outcome of surgery, patient questionnaire. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 150 |
| Key inclusion criteria | Adults following cataract surgery uncomplicated by operative problems. Chosen randomly at preoperative assessment. |
| Key exclusion criteria | 1. Intraoperative complications 2. Existing ocular pathology 3. Patients with one good seeing eye |
| Date of first enrolment | 19/06/2003 |
| Date of final enrolment | 01/12/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
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 |
Editorial Notes
25/03/2020: No publications found, all search options exhausted, study status unverified.
