PresbyopiaNCT06963138
Comparative Study and Validation of New Methodologies for Measuring Addition
A study testing Visual Acuity, Objective refraction and Standard Subjective refraction in people with Presbyopia and Near Vision, run by Essilor International at 1 site in France.
Trial summary
The aim of this research is to collect comprehensive data on a presbyopic population that may require near vision correction, in order to identify the most useful tests to accurately determine the value of an addition. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Near Vision, Refraction Error
- What is being tested?
- Visual Acuity, Objective refraction and Standard Subjective refraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2025to 5 May 2025
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
- Aged 40 to 60 years
- Individual with monocular visual acuity ≥ +0.1 LogMAR with current corrections and pinhole if necessary
- Individual with a visual acuity difference ≤ 0.2 LogMAR with current corrections
- Individual with stable binocular vision in distance and near vision
Who cannot join
- Age < 40 years (i.e., no minors in accordance with Article L1121-7)
- Age > 60 years
- All categories of people specifically protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code):
- Pregnant, childbearing, or breastfeeding women (Article L1121-5)
- Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social care facility for purposes other than research
- Adults incapable or unable to express consent (Article L1121-8)
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- Participants currently excluded from another study
- Participants unable to be contacted in case of emergency
- Person with strabismus
- Person with amblyopia
- Aphakic or pseudophakic person
- Person with vertical phoria > 1 PD
- Declared neurological deficit, including a history of epileptic disorders or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders)
- Declared severe ocular pathology, involving visual field loss, such as glaucoma, or involving loss of acuity and significant discomfort in dimly or excessively lit environments, such as retinitis pigmentosa, or declared and treated dry eye.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research is to collect comprehensive data on a presbyopic population that may require near vision correction, in order to identify the most useful tests to accurately determine the value of an addition.
Read the detailed description
Refraction is the key point of an ophthalmic examination when visual correction is required for distance vision, as is determining the addition for near vision. These measurements can be obtained objectively and/or subjectively.
The addition for near vision is most often obtained using so-called subjective devices, i.e., by relying on the patient's responses.
The state of the accommodative system can, however, be measured objectively using instruments available to prescribers (retinoscopes, automatic refractometers, aberrometers, etc.). These measurements can be used in clinical practice as a solid basis for the initial assessment of the subject's refractive status during a comprehensive eye examination. However, these measurements are not sufficient to determine the optimal correction to prescribe for near vision, i.e., one that achieves sufficient visual acuity and comfort to ensure effectiveness for the tasks a person wishes to perform in their daily life.
Indeed, subjective tests are considered the gold standard for prescribers, particularly when it comes to near vision testing. Also, there are numerous procedures for determining the appropriate addition to prescribe, and a wide variety of practices is observed among prescribers around the world. It is often necessary to perform multiple tests to ensure the correct addition value to recommend.
The aim of this study is to find ways of approaching the value of the ideal addition as accurately as possible, based on several parameters: measurements representative of subjects' near vision habits, optometric measurements to determine near vision addition, and measurements related to binocular vision and symptomatology. This data collection will enable to identify the most effective combination of measurements in order to determine the optimal near vision addition for a subject.
- Conditions
- Presbyopia, Near Vision, Refraction Error
- Being tested
- Visual Acuity, Objective refraction, Standard Subjective refraction, Near vision examination and determination of additions, Binocular vision tests
- Medical subject headings
- Presbyopia, Myopia, Refractive Errors
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 for near and distance vision with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Objective refractionDevice
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer
Standard Subjective refractionDevice
Standard subjective refraction for distance vision will be performed with Vision-R™
Near vision examination and determination of additionsDevice
Near vision examination and determination of additions will be performed with Vision-R™. The following objective and subjective measurement methods will determine the values of the various additions:
- Determination of addition using the retinoscopy method (Add_OBJ)
- Randomization and administration of addition determination tests: FCC; R/G; PRA-NRA
Binocular vision testsDevice
The following measurements will be taken in trial glasses equipped with the final addition:
- Stereoscopic acuity measurement
- Measurement of the Near Point of Accommodation (PPA)
- Measurement of the Near Point of Convergence (PPC)
- Measurement of fusion reserves
- Measurement of prismatic rock
- Subjective questionnaire on the different methods used
Extended trial of additionDevice
The following measurements will be performed using trial glasses equipped with the final addition:
- Submission of the CISS questionnaire and distance adaptation
- Initial measurements of accommodative positioning and phorias
- Completion of three smartphone tasks: reading, memorization, and video viewing
- Final measurements of accommodative positioning and phorias
- Submission of the QoL questionnaire regarding visual discomfort during the trial.
| Study group | Role | What they receive |
|---|---|---|
| Validation of new addition measurement methodologies | Experimental | Not described Receives: Device: Visual Acuity; Device: Objective refraction; Device: Standard Subjective refraction; Device: Near vision examination and determination of additions; Device: Binocular vision tests; Device: Extended trial of addition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's age
The subject's age is requested via the Case Report Form
Measured: Day 1
Addition value given by the objective method
When you have presbyopia, the lens is no longer able to increase its power to accommodate near vision. It must then be helped by adding power for near vision, i.e., increasing the strength of the lens: this is called addition. The value of the addition is expressed in diopters (D) and is automatically measured by an auto-kerato-refractometer/aberrometer. It is an objective measure because it does not call upon the subject's responses when presented with acuity scales.
Measured: Day 1
Addition value given by the subjective method
When you have presbyopia, the lens is no longer able to increase its power to accommodate near vision. It must then be helped by adding power for near vision, i.e., increasing the strength of the lens: this is called addition. The value of the addition is expressed in diopters (D) and is automatically measured by an autorefractometer. It is a subjective measure because it calls upon the subject's responses when presented with acuity scales.
Measured: Day 1
Working distances for near vision
Several working distances are measured for near vision. The values of the distances are expressed in centimeters (cm).
The various working distances for near vision are:
- Harmon distance: the morphological distance from the elbow to the clenched fist
- Revip distance (visuo-postural reflex): the subject is given a blank A4 sheet of paper and asked to hold it at their potential reading distance.
- Desired distance: the distance at which a subject can read a Times 12 text on an A4 sheet of paper.
Measured: Day 1
Secondary outcomes (2)
Quality of Vision questionnaire (Qov) score
The QoV Questionnaire consists of a Rasch-tested, linear-scaled, 30-item instrument on three scales providing a QoV score in terms of symptom frequency, severity, and bothersome. It is suitable for measuring QoV in patients with all types of refractive correction, eye surgery, and eye disease that cause QoV problems.
The QoV Questionnaire includes, 10 questions for each nature of evaluation (frequency, severity and bothersome) and 4 possible answers weighted by the values 0, 1, 2 or 3. The higher the score, the more frequently or intensely the symptom is perceived, or the more annoying it is, depending on the nature of the evaluation. Minimum score : 0 ; Maximum Score : 30.
Measured: Day 1
CISS questionnaire (Convergence Insufficiency Symptom Survey) score
The CISS Questionnaire consists of a 14-item instrument providing a CISS score in terms of symptom frequency. Convergence Insufficiency is a condition in which a patient finds it difficult to maintain alignment of the eyes on a near object. The assessment of potential convergence difficulties in near vision may cause a person to look with just one eye at a time, or to see double.
The Convergence Insufficiency Symptom Survey includes 5 questions relative to specific visual symptoms, with 5 possible answers weighted by the values 0, 1, 2, 3 or 4. The higher the score, the more frequently the symptom is perceived. Minimum Score : 0 ; Maximum Score : 60.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start31 Mar 2025
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François Daniel, Principal investigator, ESSILOR INTERNATIONAL - Division Instruments
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963138
- Sponsor's protocol ID
- WS10331
- Other IDs
- 2023-A00122-43
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2025
- Last updated
- 6 Jun 2025
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study and Validation of New Methodologies for Measuring Addition
- ClinicalTrials.gov ID
- NCT06963138
- Acronym / sponsor ID
- WS10331
- Conditions
- Presbyopia, Near Vision, Refraction Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 8 May 2025 (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.
The aim of this research is to collect comprehensive data on a presbyopic population that may require near vision correction, in order to identify the most useful tests to accurately determine the value of an addition.
Detailed description
Refraction is the key point of an ophthalmic examination when visual correction is required for distance vision, as is determining the addition for near vision. These measurements can be obtained objectively and/or subjectively.
The addition for near vision is most often obtained using so-called subjective devices, i.e., by relying on the patient's responses.
The state of the accommodative system can, however, be measured objectively using instruments available to prescribers (retinoscopes, automatic refractometers, aberrometers, etc.). These measurements can be used in clinical practice as a solid basis for the initial assessment of the subject's refractive status during a comprehensive eye examination. However, these measurements are not sufficient to determine the optimal correction to prescribe for near vision, i.e., one that achieves sufficient visual acuity and comfort to ensure effectiveness for the tasks a person wishes to perform in their daily life.
Indeed, subjective tests are considered the gold standard for prescribers, particularly when it comes to near vision testing. Also, there are numerous procedures for determining the appropriate addition to prescribe, and a wide variety of practices is observed among prescribers around the world. It is often necessary to perform multiple tests to ensure the correct addition value to recommend.
The aim of this study is to find ways of approaching the value of the ideal addition as accurately as possible, based on several parameters: measurements representative of subjects' near vision habits, optometric measurements to determine near vision addition, and measurements related to binocular vision and symptomatology. This data collection will enable to identify the most effective combination of measurements in order to determine the optimal near vision addition for a subject.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation of new addition measurement methodologies | Experimental | Device: Visual Acuity, Device: Objective refraction, Device: Standard Subjective refraction, Device: Near vision examination and determination of additions, Device: Binocular vision tests, Device: Extended trial of addition |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteer, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
- Aged 40 to 60 years
- Individual with monocular visual acuity ≥ +0.1 LogMAR with current corrections and pinhole if necessary
- Individual with a visual acuity difference ≤ 0.2 LogMAR with current corrections
- Individual with stable binocular vision in distance and near vision
Key exclusion criteria (14 listed)
- Age < 40 years (i.e., no minors in accordance with Article L1121-7)
- Age > 60 years
- All categories of people specifically protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code):
- Pregnant, childbearing, or breastfeeding women (Article L1121-5)
- Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social care facility for purposes other than research
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 for near and distance vision with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart | Device | Validation of new addition measurement methodologies |
| Objective refractionObjective refraction will be measured using an auto-kerato-refractometer/aberrometer | Device | Validation of new addition measurement methodologies |
| Standard Subjective refractionStandard subjective refraction for distance vision will be performed with Vision-R™ | Device | Validation of new addition measurement methodologies |
| Near vision examination and determination of additionsNear vision examination and determination of additions will be performed with Vision-R™. The following objective and subjective measurement methods will determine the values of the various additions: 1. Determination of addition using the retinoscopy method (Add_OBJ) 2. Randomization and administration of addition determination tests: FCC; R/G; PRA-NRA | Device | Validation of new addition measurement methodologies |
| Binocular vision testsThe following measurements will be taken in trial glasses equipped with the final addition: 1. Stereoscopic acuity measurement 2. Measurement of the Near Point of Accommodation (PPA) 3. Measurement of the Near Point of Convergence (PPC) 4. Measurement of fusion reserves 5. Measurement of prismatic rock 6. Subjective questionnaire on the different methods used | Device | Validation of new addition measurement methodologies |
| Extended trial of additionThe following measurements will be performed using trial glasses equipped with the final addition: 1. Submission of the CISS questionnaire and distance adaptation 2. Initial measurements of accommodative positioning and phorias 3. Completion of three smartphone tasks: reading, memorization, and video viewing 4. Final measurements of accommodative positioning and phorias 5. Submission of the QoL questionnaire regarding visual discomfort during the trial. | Device | Validation of new addition measurement methodologies |
Primary outcome
Subject's age
Time frame: Day 1
The subject's age is requested via the Case Report Form
Addition value given by the objective method
Time frame: Day 1
When you have presbyopia, the lens is no longer able to increase its power to accommodate near vision. It must then be helped by adding power for near vision, i.e., increasing the strength of the lens: this is called addition. The value of the addition is expressed in diopters (D) and is automatically measured by an auto-kerato-refractometer/aberrometer. It is an objective measure because it does not call upon the subject's responses when presented with acuity scales.
Addition value given by the subjective method
Time frame: Day 1
When you have presbyopia, the lens is no longer able to increase its power to accommodate near vision. It must then be helped by adding power for near vision, i.e., increasing the strength of the lens: this is called addition. The value of the addition is expressed in diopters (D) and is automatically measured by an autorefractometer. It is a subjective measure because it calls upon the subject's responses when presented with acuity scales.
Working distances for near vision
Time frame: Day 1
Several working distances are measured for near vision. The values of the distances are expressed in centimeters (cm). The various working distances for near vision are: * Harmon distance: the morphological distance from the elbow to the clenched fist * Revip distance (visuo-postural reflex): the subject is given a blank A4 sheet of paper and asked to hold it at their potential reading distance. * Desired distance: the distance at which a subject can read a Times 12 text on an A4 sheet of paper.
2 secondary outcomes
Quality of Vision questionnaire (Qov) score
Time frame: Day 1
CISS questionnaire (Convergence Insufficiency Symptom Survey) score
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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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.
François Daniel 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 Standard Subjective refraction in people with Presbyopia and Near Vision, 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 6 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's age (time frame: Day 1). The study lists 4 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 6 Jun 2025.