Macular Degeneration Exudative Eye BilateralNCT03214484
The Evolution of Visual Acuity Measured by Electronic Tablet / Computer of Exudative AMD Patients
A study testing By comparing the evolution of the visual acuity curves. and By comparing the evolution of the curves. in people with Macular Degeneration Exudative Eye Bilateral, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration Exudative Eye Bilateral
- What is being tested?
- By comparing the evolution of the visual acuity curves. and By comparing the evolution of the curves.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Saint Joseph
Marseille, 13008
Frédéric QUEGUINER, MD, +33 0491806793, fqueguiner@hopital-saint-joseph.fr
About this study
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.
Read more
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
Read the 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.
- Being tested
- By comparing the evolution of the visual acuity curves., By comparing the evolution of the curves.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
By comparing the evolution of the visual acuity curves.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.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.
| Study group | Role | What they receive |
|---|---|---|
| electronc tablet | Active comparator | 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. Receives: Other: By comparing the evolution of the visual acuity curves.; Other: By comparing the evolution of the curves. |
| computer | Active comparator | 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. Receives: Other: By comparing the evolution of the visual acuity curves.; Other: By comparing the evolution of the curves. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
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.
Measured: Month 1
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.
Measured: Month 2
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.
Measured: Month 3
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.
Measured: Month 4
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.
Measured: Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start2 Jun 2017
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration Exudative Eye BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frédéric QUEGUINER, MD, Hospital St. Joseph, Marseille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214484
- Sponsor's protocol ID
- Sight Study
- Status last verified
- Jul 2017
- First submitted
- 31 May 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03214484
- Acronym / sponsor ID
- Sight Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| electronc tablet | Active comparator | Other: By comparing the evolution of the visual acuity curves., Other: By comparing the evolution of the curves.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. |
| computer | Active comparator | Other: By comparing the evolution of the visual acuity curves., Other: By comparing the evolution of the curves.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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | computer, electronc tablet |
| 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. | Other | computer, electronc tablet |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing By comparing the evolution of the visual acuity curves. and By comparing the evolution of the curves. in people with Macular Degeneration Exudative Eye Bilateral, run by Hospital St. Joseph, Marseille, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie RAFFRAY, MS (+33 491806516, mraffray@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.