Clinical trial NCT03214484: The Evolution of Visual Acuity Measured by Electronic Tablet / Computer of Exudative AMD Patients
Official title: A Prospective Study Comparing the Evolution of Visual Acuity Measured by Electronic Tablet or Computer and the Visual Acuity Measured by ETDRS in Patients Monitored and Treated for Exudative AMD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Degeneration Exudative Eye Bilateral
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In total, 80 patients (40 for the Electronc Tablet group, 40 for the computeur group) will be included in the study.

Using the pre-established randomization list, in order of inclusion in the study, each patient will be assigned to one of the 2
Primary purpose: PREVENTION

Brief summary: This pathology, DMLA, whose evolution is chronic, requires regular follow-up and care (IVTs) over a long period (several months or even years).

Increasing the number of patients to be followed and treated poses increasing problems for ophthalmologists to ensure regular follow-up of patients, followed by a need for satisfactory functional results.

Moreover, this regular follow-up imposes enormous constraints on patients and their families (some children or patients are still working).

Studies are beginning to emerge on the reliability of patient follow-up in telemedicine. The use of a measure of visual acuity by patients, Electronic Tablet (TE) or computer (O), and at home, seems a logical step to help us improve the quality of patient follow-up while spacing controls.

The aim of our study is thus to demonstrate that the measurement of the VA performed by TE or O is reliable. Indeed, during the follow-up of the patients, in the case where the patient's AV decreases, and whatever the reason

Detailed description: Our aim is to compare the evolution curves of the Visual Acuity (AV) measured in each patient on Electronic Tablet (TE)/ computer(O) and on the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale, in order to check the reliability of the measurements performed by TE / O by comparing them with a well-known reference measure And is routinely practiced routinely in ophthalmology centers.

Measurement of visual acuity on TE / O will be carried out on an ETDRS AV scale, the size of the letters having been adapted to the reading distance (80 cm by 0.40 cm on the tablet). An ETDRS intermediate vision (EVI) or meadow vision (TEU) score according to the group will be established in the same way. The VA measurement will be supervised by a CRA trained to the extent of the VA, without the orthoptist or ophthalmologist being informed of the results obtained.

Eligibility criteria: Inclusion Criteria:

* Male or female over 50 years of age.
* Patient monitored and treated in the department by intravitreal injections of anti VEGF (aflibercept or ranibizumab) in the indication of treatment.
* Patient with exudative AMD
* Patient who consented to participate in the study
* Patient who is able to understand the study and use a TE / O
* Patient with AV greater than or equal to 20/100
* Patient affiliated to a health

Exclusion Criteria:

* Patient having expressed his / her refusal on the collection of the medical data of his file at the end of the study
* Patient treated with non-AMD pathology
* Patient with AV less than 20/100
* Vulnerable person: protected by the law: guardianship, curatorship.
* Person participating in another test

Primary outcomes:
measure: Visual acuity
timeFrame: Day 0
measure: Visual acuity
timeFrame: Month 1
measure: Visual acuity
timeFrame: Month 2
measure: Visual acuity
timeFrame: Month 3
measure: Visual acuity
timeFrame: Month 4
measure: Visual acuity
timeFrame: Month 5
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph
Study officials:
References: