Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The learning curve for primary vitrectomy without scleral buckling for pseudophakic retinal detachment
Acronym
Study hypothesis
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
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)
Study design
Retrospective interventional case series in two academic centers.
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Reattachment rate with a single procedure at 6-month follow-up
Secondary outcome measures
1. Number of final successes
2. Number of reoperations and complications
Overall trial start date
01/05/2004
Overall trial end date
30/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients presenting with a pseudophakic retinal detachment and a Proliferative VitreoRetinopathy (PVR) grade A and B
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
280
Participant exclusion criteria
Patients presenting with a pseudophakic retinal detachment and a PVR grade C and D
Recruitment start date
01/05/2004
Recruitment end date
30/04/2006
Locations
Countries of recruitment
France
Trial participating centre
Service d'Ophtalmologie
Dijon
21000
France
Sponsor information
Organisation
Burgundy Association for Research in Ophthalmology (ABPRO) (France)
Sponsor details
Service d'Ophtalmologie
CHU General Hospital
Dijon
21000
France
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Dijon (CHU), General Hospital (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary