Research with human participants

Overview of medical research in the Netherlands

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

No registrations found.

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Ethical review
Positive opinion
Status
Pending
Health condition type
-
Study type
Observational non invasive

ID

NL-OMON20920

Source

NTR

Health condition

screening, wide field imaging

Sponsors and support

Primary sponsor :
French Health Ministry
Source(s) of monetary or material Support :
French Health Ministry

Intervention

Outcome measures

Primary outcome

Concordance between the results of image lecture and ophthalmoscopy both performed by an ophthalmologist.

Secondary outcome

Concordance between the results of image lecture performed by a paramedic (nurse, orthoptist) and ophthalmoscopy performed by an ophthalmologist.

Background summary

N/A

Study objective

Non inferiority of wide field imaging compared with ophthalmoscopy.

Study design

N/A

Intervention

1. Wide field imaging;

2. Ophthalmoscopy.

Public
Avenue General Koenig<br>
Reims University Hospital
Carl Arndt
Reims F- 51092
France
+33 326 78 70 90
carndt@chu-reims.fr
Scientific
Avenue General Koenig<br>
Reims University Hospital
Carl Arndt
Reims F- 51092
France
+33 326 78 70 90
carndt@chu-reims.fr

Inclusion criteria

The 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 criteria

1. Patients with an eye Infection;

2. Refusing to participate;

3. Minors.

Design

Study type :
Observational non invasive
Intervention model
:
Parallel
Allocation :
Non controlled trial
Masking :
Single blinded (masking used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
2500
Type :
Anticipated

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL2919
NTR-old NTR3066
Other : API 11-41
ISRCTN ISRCTN wordt niet meer aangevraagd.

Summary results

N/A