The learning curve for vitreous surgery
| ISRCTN | ISRCTN88931004 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88931004 |
| Protocol serial number | N/A |
| Sponsor | Burgundy Association for Research in Ophthalmology (ABPRO) (France) |
| Funder | University Hospital Dijon (CHU), General Hospital (France) |
- Submission date
- 04/01/2008
- Registration date
- 29/01/2008
- Last edited
- 29/01/2008
- 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
Prof Catherine Creuzot-Garcher
Scientific
Scientific
Service d'Ophtalmologie
CHU General Hospital
Dijon
21000
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Retrospective interventional case series in two academic centers. |
| Secondary study design | Non randomised controlled trial |
| Scientific title | The learning curve for primary vitrectomy without scleral buckling for pseudophakic retinal detachment |
| Study objectives | Pseudophakic retinal detachment is a complication in patients after cataract surgery. Although rare, this represents a high number of patients since the number of cataract extractions is on the rise (500,000 in France). This complication may lead to a severe loss of visual acuity. In this study we aim to evaluate the learning curve of junior surgeons in performing primary vitrectomy without scleral buckling for pseudophakic retinal detachment. |
| Ethics approval(s) | Ethics Committee for the Protection of Human Subjects in Biomedical Research, Bourgogne (Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale de Bourgogne). Date of approval: 4 Marth 2004 (ref: 2004/19) |
| Health condition(s) or problem(s) studied | Pseudophakic retinal detachment |
| Intervention | Surgical procedure with pars plana vitrectomy under local anesthesia. Drainage of subretinal fluid through the retinal break or a retinotomy. External cryotherapy on the retinal tears. At the end of the procedure, air-gas exchange with inexpansible gas mixture. No scleral buckling added. |
| Intervention type | Other |
| Primary outcome measure(s) |
Reattachment rate with a single procedure at 6-month follow-up |
| Key secondary outcome measure(s) |
1. Number of final successes |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 280 |
| Key inclusion criteria | Patients presenting with a pseudophakic retinal detachment and a Proliferative VitreoRetinopathy (PVR) grade A and B |
| Key exclusion criteria | Patients presenting with a pseudophakic retinal detachment and a PVR grade C and D |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- France
Study participating centre
Service d'Ophtalmologie
Dijon
21000
France
21000
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
