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Trial record 34 of 80602 for:    measured

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

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ClinicalTrials.gov Identifier: NCT03214484
Recruitment Status : Unknown
Verified July 2017 by Frédéric QUEGUINER, MD, Hospital St. Joseph, Marseille, France.
Recruitment status was:  Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Frédéric QUEGUINER, MD, Hospital St. Joseph, Marseille, France

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


Condition or disease Intervention/treatment Phase
Macular Degeneration Exudative Eye Bilateral Other: By comparing the evolution of the visual acuity curves. Other: By comparing the evolution of the curves. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : June 2, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Other: 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.

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.

Active Comparator: 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.

Other: 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.

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.




Primary Outcome Measures :
  1. Visual acuity [ Time Frame: Day 0 ]
    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.

  2. Visual acuity [ Time Frame: Month 1 ]
    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.

  3. Visual acuity [ Time Frame: Month 2 ]
    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.

  4. Visual acuity [ Time Frame: Month 3 ]
    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.

  5. Visual acuity [ Time Frame: Month 4 ]
    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.

  6. Visual acuity [ Time Frame: Month 5 ]
    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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214484


Contacts
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Contact: Marie RAFFRAY, MS +33 491806516 mraffray@hopital-saint-joseph.fr

Locations
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France
Hopital Saint Joseph Recruiting
Marseille, France, 13008
Contact: Frédéric QUEGUINER, MD    +33 0491806793    fqueguiner@hopital-saint-joseph.fr   
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France

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Responsible Party: Frédéric QUEGUINER, MD, Ophtalmologist Principal Investigator, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT03214484     History of Changes
Other Study ID Numbers: Sight Study
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases