Randomised controlled trial of reconstruction against secondary intention healing of defects of the medial canthus
| ISRCTN | ISRCTN65017165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65017165 |
| Protocol serial number | N0192080944 |
| Sponsor | Department of Health (UK) |
| Funder | Nottingham University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 01/09/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 AJE Foss
Scientific
Scientific
Department of Ophthalmology
B Floor, South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 9249924 (44249) |
|---|---|
| alexander.foss@nuh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised controlled trial of reconstruction against secondary intention healing of defects of the medial canthus |
| Study objectives | How do the results of formal reconstruction of defects of the medial canthus compare against healing by secondary intention, following tumour excision? 01/09/2015: Trial was abondoned in 1999 due to an inability to recruit participants as all patients wanted to be in the intervention group. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Reconstruction of medial canthus |
| Intervention | Randomised controlled trial. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Snelen visual acuity, diplopia, patency of lacrimal system, lid mal-positions, features of corneal exposure, photographs with four expressions, quality of life assessment. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1999 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Key inclusion criteria | 60>, Caucasian, less than 1/3 of either upper or lower lid being involved, dimension of defect must measure less than 4x4 cm, the centre of the defect must be within 1.5 cm of the medial canthal tendon. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 17/02/1999 |
| Date of final enrolment | 31/12/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Ophthalmology
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
