Macular Degeneration Exudative Eye Bilateral Clinical Trial
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
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
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | June 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hopital Saint Joseph | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital St. Joseph, Marseille, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual acuity | Visual acuity will be evaluated by Electronic Tablet (TE) and Early Treatment of Diabetic Retinopathy Study (ETDRS scale) for the first group of patients, and by computer (O) and ETDRS for the second group of patients. | Day 0 | |
| Primary | Visual acuity | Visual acuity will be evaluated by Electronic Tablet (TE) and Early Treatment of Diabetic Retinopathy Study (ETDRS scale) for the first group of patients, and by computer (O) and ETDRS for the second group of patients. | Month 1 | |
| Primary | Visual acuity | Visual acuity will be evaluated by Electronic Tablet (TE) and Early Treatment of Diabetic Retinopathy Study (ETDRS scale) for the first group of patients, and by computer (O) and ETDRS for the second group of patients. | Month 2 | |
| Primary | Visual acuity | Visual acuity will be evaluated by Electronic Tablet (TE) and Early Treatment of Diabetic Retinopathy Study (ETDRS scale) for the first group of patients, and by computer (O) and ETDRS for the second group of patients. | Month 3 | |
| Primary | Visual acuity | Visual acuity will be evaluated by Electronic Tablet (TE) and Early Treatment of Diabetic Retinopathy Study (ETDRS scale) for the first group of patients, and by computer (O) and ETDRS for the second group of patients. | Month 4 | |
| Primary | Visual acuity | Visual acuity will be evaluated by Electronic Tablet (TE) and Early Treatment of Diabetic Retinopathy Study (ETDRS scale) for the first group of patients, and by computer (O) and ETDRS for the second group of patients. | Month 5 |