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

Primary Purpose

Macular Degeneration Exudative Eye Bilateral

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
By comparing the evolution of the visual acuity curves.
By comparing the evolution of the curves.
Sponsored by
Hospital St. Joseph, Marseille, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macular Degeneration Exudative Eye Bilateral

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Saint JosephRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

electronc tablet

computer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2017
Last Updated
July 10, 2017
Sponsor
Hospital St. Joseph, Marseille, France
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1. Study Identification

Unique Protocol Identification Number
NCT03214484
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital St. Joseph, Marseille, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration Exudative Eye Bilateral

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electronc tablet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
computer
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
By comparing the evolution of the visual acuity curves.
Intervention Description
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
Intervention Name(s)
By comparing the evolution of the curves.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual acuity
Description
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.
Time Frame
Day 0
Title
Visual acuity
Description
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.
Time Frame
Month 1
Title
Visual acuity
Description
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.
Time Frame
Month 2
Title
Visual acuity
Description
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.
Time Frame
Month 3
Title
Visual acuity
Description
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.
Time Frame
Month 4
Title
Visual acuity
Description
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.
Time Frame
Month 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie RAFFRAY, MS
Phone
+33 491806516
Email
mraffray@hopital-saint-joseph.fr
Facility Information:
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric QUEGUINER, MD
Phone
+33 0491806793
Email
fqueguiner@hopital-saint-joseph.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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