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Wide field screening of retinal lesions in 2 french outpatient clinics.


- candidate number10344
- NTR NumberNTR3066
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-sep-2011
- Secondary IDsAPI 11-41 
- Public TitleWide field screening of retinal lesions in 2 french outpatient clinics.
- Scientific TitleWide field screening of retinal lesions in an outpatient clinic.
- ACRONYM
- hypothesisNon inferiority of wide field imaging compared with ophthalmoscopy.
- Healt Condition(s) or Problem(s) studiedScreening, Wide field imaging
- Inclusion criteriaThe two first patients received both in the morning (beginning at 9:00) and in the afternoon (beginning at 14:00) in two French outpatient clinics (Reims and Nancy).
- Exclusion criteria1. Patients with an eye Infection;
2. Refusing to participate;
3. Minors.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 30-sep-2011
- planned closingdate1-dec-2012
- Target number of participants2500
- Interventions1. Wide field imaging;
2. Ophthalmoscopy.
- Primary outcomeConcordance between the results of image lecture and ophthalmoscopy both performed by an ophthalmologist.
- Secondary outcomeConcordance between the results of image lecture performed by a paramedic (nurse, orthoptist) and ophthalmoscopy performed by an ophthalmologist.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Carl Arndt
- CONTACT for SCIENTIFIC QUERIES Carl Arndt
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
French Health Ministry
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD14-sep-2011 - 29-sep-2011


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