Accommodation DisorderNCT06331780
Refractive Status and Accommodation Response Under Different Experimental Conditions.
A study testing Visual acuity, Objective refraction and Objective monocular accommodation amplitude measurement in people with Accommodation Disorder and Accommodative Fatigue, run by Essilor International at 1 site in France.
Trial summary
Eye Care Professionals (ECPs) massively use auto-refractors during the patient journey to measure the objective refractive error: starting point of the subjective eye refraction. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Accommodation Disorder, Accommodative Fatigue, Accommodative Inertia
- What is being tested?
- Visual acuity, Objective refraction and Objective monocular accommodation amplitude measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2024to 31 Dec 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer: man or woman from 18 to 40 years old,
- Subject declares that his last visit to an ophthalmologist was less than 12 months ago,
- Subjects without a reported pathology, deficit or disorder that can interfere with visual or cognitive functions,
- Subjects, healthy volunteers who have been fully informed of the investigation and signed the informed consent form of the investigation,
- Subjects available for the investigation visits (at least 2 hours),
- Subjects able to appoint a visit in the investigator's site,
- Subjects able to read and understand the protocol (in French), follow the instructions, and give their informed consent approval.
Who cannot join
- Subjects with spherical equivalent wearing compensation (or fully compensate by contact lenses) ranging out from -3.00 to + 3.00 Dioptres in both eyes,
- Subjects with an astigmatism wearing compensation (or fully compensate by contact lenses) more than 1.00 Dioptres (>1,00DC) in both eyes,
- Subjects with a best compensated monocular VA < 8/10 (>0.1logMAR),
- Persons subject to a legal protection measure (guardianship, curatorship, safeguard of justice, etc.) or unable to express their consent (see Article L 1121-8 of the CSP)
- Persons deprived of their liberty by judicial or administrative decision and persons hospitalised without their consent (article L1121-6 of the CSP),
- Subjects under exclusion period from another investigation,
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- Women pregnant or breastfeeding; (Article L1121-5),
- Subjects with a reported neurologic disorder, particularly epileptic or sensory motor troubles,
- Subjects with implanted electronic medical device such as (pacemaker or hearing aid),
- Subjects with a reported severe ocular disease leading to a visual field decrease, VA deficiency or glare sensitivity,
- Subjects with monophtalmia
- Subjects who had ocular surgeries (including aphakia or pseudophakia (intraocular lenses), refractive surgery or trauma),
- Subjects who are ESSILOR INTERNATIONAL employees
- Subjects who are not affiliated to a social security scheme or are beneficiaries of such a scheme (article L1121-8-1 of the CSP).
- Subject with fixation disorder: impossibility to maintain fixation on visual target.
- Subjects who cannot stay comfortable during the tests (e.g. with neck pain ...).
- Pupil abnormality (unusual shape, size <3mm)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Essilor International - Ci&T 2
Créteil, 94000
Jérôme Gillet, +33 (0)1 49 80 63 40, gilletj@essilor.fr
About this study
Eye Care Professionals (ECPs) massively use auto-refractors during the patient journey to measure the objective refractive error: starting point of the subjective eye refraction. These devices provide objective information about the refractive and accommodative state of the eye, useful for the ECP to perform a complete eyesight test. Auto-refractor data for the distance vision are repeatable and accurate but near vision information are not enough reliable to build an accurate near vision routine exam. Previous internal studies, with auto refractors currently on the market, have shown that, during accommodation measurements, a large proportion of participants had a lower accommodative response than expected.
Read the detailed description
Clinical Development stage and rationale
The clinical development stage is pilot stage as defined in ISO 14155:2020 (Annex I section 1.3.2).This clinical investigation is an exploratory clinical investigation as mentioned in the Medical Device Regulation EU 745/2017, also named early feasibility clinical investigation in the ISO 14155:2020. The necessity of such clinical investigations is more precisely described by the Food and Drug Administration (FDA) (Attachment E CDRH Final Guidance Cover Sheet) and Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), where they detail the importance of exploratory studies in pivotal investigation design.
Medical devices often undergo design improvement during development, with refinement during lifecycles beginning with early research, extending through investigational use and initial marketing of the approved or cleared product, and continuing to subsequently approved or cleared commercial device versions.
Objectives and hypotheses of the clinical investigation
This clinical investigation explores new ways of measuring accommodative response, particularly regarding the dynamics and amplitude of response: we chose to vary several parameters.
- Being tested
- Visual acuity, Objective refraction, Objective monocular accommodation amplitude measurement, Subjective monocular accommodation amplitude measurement with the "Push-Up" method, Subjective monocular accommodation facility measurement with the "Rock" method:
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual acuityDevice
VA will be measured with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Objective refractionDevice
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer
Objective monocular accommodation amplitude measurementDevice
Objective monocular accommodation amplitude measurements are obtained dynamically by measuring the subject's dioptric change while the participant focuses on a virtual object that moves from distance
Subjective monocular accommodation amplitude measurement with the "Push-Up" methodDevice
The subjective monocular accommodation amplitude measurements are carried out by the "push-up" method and proceeds as follows:
- The ECP presents a near vision test card corresponding to a 0.8 (8/10) acuity line, or the smallest readable line if acuity is poor, or the smallest readable text.
- Instructions to the subject: "Look at the smallest line of letters and try to see them clearly for as long as possible when I bring them closer; tell me when they start to blur and stay blurred.
- The ECP slowly brings the test card closer
- The ECP note the distance of the test card from the glasses as soon as the vision is blurred. Continue to move the test closer to check that vision remains blurred.
The amount of accommodation in this eye is equal to the proximity (= 1/distance) of the test when the blur is just perceived.
Subjective monocular accommodation facility measurement with the "Rock" method:Device
The subjective monocular accommodation facility measurements are carried out by the "Rock" method and proceeds as follows:
- The ECP presents at 40cm a near vision test card corresponding to 80% of the VA.
- The ECP gives to the participant a flipper +/- 2 Dioptre
- Instructions to the subject: "Look at the test" and add the -2.00 D (Sphere) flipper, as soon as it's clear, return the flipper to present a +2.00 D (Sphere), as soon as it's clear, return the flipper etc… You have to do the maximum number of rotations in one minute.
CISS QuestionnaireOther
This questionnaire relating to the use of the near vision will be submitted
Difficulty assessment questionnaireOther
After each near vision measurement, the participant should rate, on a Visual Analogic Score (0-10), the difficulty encountered, from 0: extremely easy to 10: extremely difficult. The participant may also specify the reasons for the difficulty(ies) encountered during the measurement.
Subjective evaluation questionnaireOther
A subjective evaluation questionnaire will be submitted to the participants at the end of the visit.
| Study group | Role | What they receive |
|---|---|---|
| Closed-field Aberrometer | Experimental | Objective refraction at different distances with Shack-Hartmann Aberrometer Receives: Device: Visual acuity; Device: Objective refraction; Device: Objective monocular accommodation amplitude measurement; Device: Subjective monocular accommodation amplitude measurement with the "Push-Up" method; Device: Subjective monocular accommodation facility measurement with the "Rock" method:; Other: CISS Questionnaire; Other: Difficulty assessment questionnaire; Other: Subjective evaluation questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodative response measured with closed-field aberrometer with different target displacement methods
Accommodative response (Dioptries)
Measured: One day (measurements are taken during the single visit)
Accommodative response measured with closed-field aberrometer with different displayed targets
Accommodative response (Dioptries)
Measured: One day (measurements are taken during the single visit)
Objective refraction measured with closed-field aberrometer and two camera exposure times
Sphere (Dioptries), Cylinder (Dioptries), Axis (°) and High Order Aberrations (Zernike polynomials)
Measured: One day (measurements are taken during the single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start22 Feb 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accommodation DisorderStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jérôme Gillet, Principal investigator, ESSILOR INTERNATIONAL - Division Instruments
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331780
- Sponsor's protocol ID
- WS10370
- Other IDs
- 2023-A02153-42
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Status and Accommodation Response Under Different Experimental Conditions.
- ClinicalTrials.gov ID
- NCT06331780
- Acronym / sponsor ID
- WS10370
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Mar 2024 (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.
Eye Care Professionals (ECPs) massively use auto-refractors during the patient journey to measure the objective refractive error: starting point of the subjective eye refraction. These devices provide objective information about the refractive and accommodative state of the eye, useful for the ECP to perform a complete eyesight test. Auto-refractor data for the distance vision are repeatable and accurate but near vision information are not enough reliable to build an accurate near vision routine exam. Previous internal studies, with auto refractors currently on the market, have shown that, during accommodation measurements, a large proportion of participants had a lower accommodative response than expected.
Detailed description
Clinical Development stage and rationale
The clinical development stage is pilot stage as defined in ISO 14155:2020 (Annex I section 1.3.2).This clinical investigation is an exploratory clinical investigation as mentioned in the Medical Device Regulation EU 745/2017, also named early feasibility clinical investigation in the ISO 14155:2020. The necessity of such clinical investigations is more precisely described by the Food and Drug Administration (FDA) (Attachment E CDRH Final Guidance Cover Sheet) and Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), where they detail the importance of exploratory studies in pivotal investigation design.
Medical devices often undergo design improvement during development, with refinement during lifecycles beginning with early research, extending through investigational use and initial marketing of the approved or cleared product, and continuing to subsequently approved or cleared commercial device versions.
Objectives and hypotheses of the clinical investigation
This clinical investigation explores new ways of measuring accommodative response, particularly regarding the dynamics and amplitude of response: we chose to vary several parameters.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed-field Aberrometer | Experimental | Device: Visual acuity, Device: Objective refraction, Device: Objective monocular accommodation amplitude measurement, Device: Subjective monocular accommodation amplitude measurement with the "Push-Up" method, Device: Subjective monocular accommodation facility measurement with the "Rock" method:, Other: CISS Questionnaire, Other: Difficulty assessment questionnaire, Other: Subjective evaluation questionnaireObjective refraction at different distances with Shack-Hartmann Aberrometer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Volunteer: man or woman from 18 to 40 years old,
- Subject declares that his last visit to an ophthalmologist was less than 12 months ago,
- Subjects without a reported pathology, deficit or disorder that can interfere with visual or cognitive functions,
- Subjects, healthy volunteers who have been fully informed of the investigation and signed the informed consent form of the investigation,
- Subjects available for the investigation visits (at least 2 hours),
Key exclusion criteria (17 listed)
- Subjects with spherical equivalent wearing compensation (or fully compensate by contact lenses) ranging out from -3.00 to + 3.00 Dioptres in both eyes,
- Subjects with an astigmatism wearing compensation (or fully compensate by contact lenses) more than 1.00 Dioptres (>1,00DC) in both eyes,
- Subjects with a best compensated monocular VA < 8/10 (>0.1logMAR),
- Persons subject to a legal protection measure (guardianship, curatorship, safeguard of justice, etc.) or unable to express their consent (see Article L 1121-8 of the CSP)
- Persons deprived of their liberty by judicial or administrative decision and persons hospitalised without their consent (article L1121-6 of the CSP),
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 |
|---|---|---|
| Visual acuityVA will be measured with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart | Device | Closed-field Aberrometer |
| Objective refractionObjective refraction will be measured using an auto-kerato-refractometer/aberrometer | Device | Closed-field Aberrometer |
| Objective monocular accommodation amplitude measurementObjective monocular accommodation amplitude measurements are obtained dynamically by measuring the subject's dioptric change while the participant focuses on a virtual object that moves from distance | Device | Closed-field Aberrometer |
| Subjective monocular accommodation amplitude measurement with the "Push-Up" methodThe subjective monocular accommodation amplitude measurements are carried out by the "push-up" method and proceeds as follows: * The ECP presents a near vision test card corresponding to a 0.8 (8/10) acuity line, or the smallest readable line if acuity is poor, or the smallest readable text. * Instructions to the subject: "Look at the smallest line of letters and try to see them clearly for as long as possible when I bring them closer; tell me when they start to blur and stay blurred. * The ECP slowly brings the test card closer * The ECP note the distance of the test card from the glasses as soon as the vision is blurred. Continue to move the test closer to check that vision remains blurred. The amount of accommodation in this eye is equal to the proximity (= 1/distance) of the test when the blur is just perceived. | Device | Closed-field Aberrometer |
| Subjective monocular accommodation facility measurement with the "Rock" method:The subjective monocular accommodation facility measurements are carried out by the "Rock" method and proceeds as follows: * The ECP presents at 40cm a near vision test card corresponding to 80% of the VA. * The ECP gives to the participant a flipper +/- 2 Dioptre * Instructions to the subject: "Look at the test" and add the -2.00 D (Sphere) flipper, as soon as it's clear, return the flipper to present a +2.00 D (Sphere), as soon as it's clear, return the flipper etc… You have to do the maximum number of rotations in one minute. | Device | Closed-field Aberrometer |
| CISS QuestionnaireThis questionnaire relating to the use of the near vision will be submitted | Other | Closed-field Aberrometer |
| Difficulty assessment questionnaireAfter each near vision measurement, the participant should rate, on a Visual Analogic Score (0-10), the difficulty encountered, from 0: extremely easy to 10: extremely difficult. The participant may also specify the reasons for the difficulty(ies) encountered during the measurement. | Other | Closed-field Aberrometer |
| Subjective evaluation questionnaireA subjective evaluation questionnaire will be submitted to the participants at the end of the visit. | Other | Closed-field Aberrometer |
Primary outcome
Accommodative response measured with closed-field aberrometer with different target displacement methods
Time frame: One day (measurements are taken during the single visit)
Accommodative response (Dioptries)
Accommodative response measured with closed-field aberrometer with different displayed targets
Time frame: One day (measurements are taken during the single visit)
Accommodative response (Dioptries)
Objective refraction measured with closed-field aberrometer and two camera exposure times
Time frame: One day (measurements are taken during the single visit)
Sphere (Dioptries), Cylinder (Dioptries), Axis (°) and High Order Aberrations (Zernike polynomials)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
Jérôme Gillet principal investigator
ESSILOR INTERNATIONAL - Division Instruments
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual acuity, Objective refraction and Objective monocular accommodation amplitude measurement in people with Accommodation Disorder and Accommodative Fatigue, run by Essilor International 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 17 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 26 Mar 2024. 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 Thierry Laloux (+33 (1) 55 96 54 05, lalouxt@essilor.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accommodative response measured with closed-field aberrometer with different target displacement methods (time frame: One day (measurements are taken during the single visit)). The study lists 3 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 26 Mar 2024.