Condition category
Eye Diseases
Date applied
04/01/2008
Date assigned
29/01/2008
Last edited
29/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Catherine Creuzot-Garcher

ORCID ID

Contact details

Service d'Ophtalmologie
CHU General Hospital
Dijon
21000
France

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

http://www.chu-dijon.fr

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

Publication citations

Additional files

Editorial Notes