The Evolution of Visual Acuity Measured by Electronic Tablet / Computer of Exudative AMD Patients

NCT ID: NCT03214484

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-02

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Macular Degeneration Exudative Eye Bilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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electronc tablet

On ET or Computer, the AV is measured at a closer distance (40 cm and 80 cm, respectively). At this closer distance (ie near and near vision), the eccentric fixation is much more Difficult to perform, unnatural, often requiring learning in the context of low vision rehabilitation.

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.

Group Type ACTIVE_COMPARATOR

By comparing the evolution of the visual acuity curves.

Intervention Type OTHER

By comparing the evolution of the curves, the investigator can confirm that the AV measured on ET / Computer can be an interesting and useful element to help us follow up our patients and improve the quality of life's patients by decreasing the number of visits control.

By comparing the evolution of the curves.

Intervention Type OTHER

By comparing the evolution of the curves, the investigator can confirm that the AV measured on ET / Computer can be an interesting and useful element to help us follow up our patients and improve the quality of life's patients by decreasing the number of visits control.

computer

On ET or Computer, the AV is measured at a closer distance (40 cm and 80 cm, respectively). At this closer distance (ie near and near vision), the eccentric fixation is much more Difficult to perform, unnatural, often requiring learning in the context of low vision rehabilitation.

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.

Group Type ACTIVE_COMPARATOR

By comparing the evolution of the visual acuity curves.

Intervention Type OTHER

By comparing the evolution of the curves, the investigator can confirm that the AV measured on ET / Computer can be an interesting and useful element to help us follow up our patients and improve the quality of life's patients by decreasing the number of visits control.

By comparing the evolution of the curves.

Intervention Type OTHER

By comparing the evolution of the curves, the investigator can confirm that the AV measured on ET / Computer can be an interesting and useful element to help us follow up our patients and improve the quality of life's patients by decreasing the number of visits control.

Interventions

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By comparing the evolution of the visual acuity curves.

By comparing the evolution of the curves, the investigator can confirm that the AV measured on ET / Computer can be an interesting and useful element to help us follow up our patients and improve the quality of life's patients by decreasing the number of visits control.

Intervention Type OTHER

By comparing the evolution of the curves.

By comparing the evolution of the curves, the investigator can confirm that the AV measured on ET / Computer can be an interesting and useful element to help us follow up our patients and improve the quality of life's patients by decreasing the number of visits control.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role lead

Responsible Party

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Frédéric QUEGUINER, MD

Ophtalmologist Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hopital Saint Joseph

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie RAFFRAY, MS

Role: CONTACT

+33 491806516

Facility Contacts

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Frédéric QUEGUINER, MD

Role: primary

+33 0491806793

Other Identifiers

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Sight Study

Identifier Type: -

Identifier Source: org_study_id

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