ISRCTN ISRCTN88931004
DOI https://doi.org/10.1186/ISRCTN88931004
Secondary identifying numbers N/A
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

Service d'Ophtalmologie
CHU General Hospital
Dijon
21000
France

Study information

Study designRetrospective interventional case series in two academic centers.
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe learning curve for primary vitrectomy without scleral buckling for pseudophakic retinal detachment
Study objectivesPseudophakic 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) studiedPseudophakic retinal detachment
InterventionSurgical 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 typeOther
Primary outcome measureReattachment rate with a single procedure at 6-month follow-up
Secondary outcome measures1. Number of final successes
2. Number of reoperations and complications
Overall study start date01/05/2004
Completion date30/04/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants280
Key inclusion criteriaPatients presenting with a pseudophakic retinal detachment and a Proliferative VitreoRetinopathy (PVR) grade A and B
Key exclusion criteriaPatients presenting with a pseudophakic retinal detachment and a PVR grade C and D
Date of first enrolment01/05/2004
Date of final enrolment30/04/2006

Locations

Countries of recruitment

  • France

Study participating centre

Service d'Ophtalmologie
Dijon
21000
France

Sponsor information

Burgundy Association for Research in Ophthalmology (ABPRO) (France)
Research organisation

Service d'Ophtalmologie
CHU General Hospital
Dijon
21000
France

Website http://www.chu-dijon.fr

Funders

Funder type

Hospital/treatment centre

University Hospital Dijon (CHU), General Hospital (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan