Healthy Young AdultsBIPBIPNCT07859917
Study in Young Adults to Understand How Glasses With a Small Reading Addition Affect Focusing and Eye Coordination During Vision Tasks
A study testing Eye exam, Questionnaires and Washout lenses in people with Healthy Young Adults and Accommodation Disorder, run by Essilor International at 1 site in United Kingdom.
Trial summary
This clinical study aims to understand how glasses with a small reading addition affect the way the eyes focus and work together in young adults with normal near vision. Some people experience focusing difficulties or visual discomfort during near-vision activities such as reading or using digital devices. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults, Accommodation Disorder
- What is being tested?
- Eye exam, Questionnaires and Washout lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Voluntary person, fluent in English willing to follow the protocol, able to read and understand the information form and give his free and informed consent
- 2.Aged between 18 and 35 years old
- 3.Non-presbyopic
- 4.Wears glasses for at least 6 hours per day
- 5.Distance refractive error (Sphere) within the range of [-6.00D to +3.00D] (with cylinder in the negative form)
- 6.Cylindrical component of the refractive error within the range of [0 to -2 D] in both eyes
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- 7.Anisometropia within the range of [0.00D to +1.50D]
- 8.A visual acuity with new prescription at distance and at near greater or equal to 20/25 (6/7.5, 0.1 logMAR) monocularly and binocularly
- 9.No visual acuity difference inferior or equal to 0.1 logMAR between right and left eye at distance and at near
- 10.Phakic eyes
- 11.Daily activities of the participant mostly in near vision (at least 6 hours during weekday)
Who cannot join
- 1.Pregnant woman or nursing
- 2.Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent and persons admitted to a health or social institution for purposes other than research
- 3.Adults who are unwilling or unable to express consent
- 4.Participant in exclusion period from another study
- 5.Persons wearing or that have previously worn any type of anti-fatigue or lenses with a boost
- 6.Persons who don't wear glasses
Show all 15Show fewer
- 7.Severe ocular pathology declared, involving a loss of visual field as in glaucoma or involving a loss of acuity and strong discomfort in environments with little or too much light as in retinitis pigmentosa or moderate or severe dry eye diagnosed.
- 8.Reported neurological deficit, including a history of epilepsy or sensorimotor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, dizziness)
- 9.Overt aphakic or pseudophakic (intraocular implant)
- 10.Constant or intermittent diplopia or double vision with a +1.00D lens at near
- 11.Ocular diseases nor general pathologies with an impact on visual field or vision.
- 12.Reported systemic condition, medical treatment or medication that affects vision
- 13.Manifest or decompensating latent strabismus, amblyopia, nystagmus.
- 14.Known contraindication to cyclopentolate 1% or its excipients
- 15.Known risk of angle-closure glaucoma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
City St Georges's, University of London
London
Miriam Conway, PhD, +44 20 7040 8392, miriam.conway.1@city.ac.uk
About this study
Official title: Impact of a Small Power Addition Lens on the Accommodative and Binocular Profiles
This clinical study aims to understand how glasses with a small reading addition affect the way the eyes focus and work together in young adults with normal near vision.
Some people experience focusing difficulties or visual discomfort during near-vision activities such as reading or using digital devices. This study will evaluate whether glasses with a small reading addition can help reduce these difficulties and improve visual comfort.
Read more
Researchers will compare two different pairs of glasses designed to provide additional support for near vision. They will assess how each pair affects eye focusing and eye coordination using standard optometric examinations.
Participants will:
- Wear three pairs of glasses, each for approximately 4 weeks.
- Complete eye examinations to evaluate focusing ability and eye coordination.
- Answer questionnaires about visual comfort, eye strain, and overall quality of vision.
- Conditions
- Healthy Young Adults, Accommodation Disorder
- Being tested
- Eye exam, Questionnaires, Washout lenses, Reference lenses, Test lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye examDevice
An optometric eye exam
QuestionnairesOther
Questionnaires on the eye fatigue and the quality of vision
Washout lensesDevice
Also called Single Vision Stylis Cz Sapph
Standard single-vision spectacle lenses prescribed according to each participant's refractive error and worn during the washout period before allocation to the study lenses.
Reference lensesDevice
Spectacles lenses optimized near vision lenses for the comparator
Test lensesDevice
Spectacles lenses optimized near vision lenses for the test
| Study group | Role | What they receive |
|---|---|---|
| 1st worn pair of glasses : Reference / 2nd worn pair of glasses : Test | Experimental | The very first pair of lenses worn before the experimental arm are washout lenses : Standard single-vision spectacle lenses prescribed according to each participant's refractive error and worn during the washout period before allocation to the study lenses. Receives: Device: Eye exam; Other: Questionnaires; Device: Washout lenses; Device: Reference lenses; Device: Test lenses |
| 1st worn pair of glasses : Test / 2nd worn pair of glasses : Reference | Experimental | The very first pair of lenses worn before the experimental arm are washout lenses : Standard single-vision spectacle lenses prescribed according to each participant's refractive error and worn during the washout period before allocation to the study lenses. Receives: Device: Eye exam; Other: Questionnaires; Device: Washout lenses; Device: Reference lenses; Device: Test lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodative facility difference
Measurement of the accommodative facility to understand the flexibility of the accommodation. It will be measured in cycle per minute (cpm) using a +/-2.00D flipper lens test at 40cm according to standard clinical accommodative facility testing procedures. Lenses are placed in front of the eyes to stimulated or not the accommodation on a text. The main goal of the participant is to keep clear and single the target while switching between the accommodative lenses and the non accommodative lenses.
The results obtained after the wearing period of each lenses will be compared together.
Measured: From enrollement to the end of the participation at about 16 weeks
Secondary outcomes (18)
Visual fatigue questionnaire score
Visual fatigue assessed using a validated questionnaire, CISS (Borsting et al, Optometry and Vision Science. 2003, 80(12):832-838). Total questionnaire scores (range 0 to 56 with a higher score meaning a higher fatigue) obtained after each lens-wear period will be compared between the reference lens and the test lens
Measured: From enrollement to the end of the participation at about 16 weeks
Visual Comfort Questionnaire Score
Visual comfort assessed using a questionnaire administered at the end of each lens-wear period. Questionnaire scores (range from 0 to 182) will be compared between the reference lens and the test lens.
Measured: From enrollement to the end of the participation at about 16 weeks
Vision Quality Questionnaire Score
Subjective quality of vision assessed using a questionnaire. Total questionnaire scores (range from 0 t o182) will be compared between the reference lens and the test lens.
Measured: From enrollement to the end of the participation at about 16 weeks
Participant Lens Preference
Participant preference for the reference lens or the test lens assessed at the completion of both lens-wear periods using a preference questionnaire.
Measured: From enrollement to the end of the participation at about 16 weeks
Near Phoria
Near phoria (in prismatic diopter) measured using standard clinical procedures. Phoria values obtained after participants wore the reference lens and the test lens will be compared.
Measured: From enrollement to the end of the participation at about 16 weeks
Sheard Criterion
Sheard criterion calculated from measurements of phoria and fusional vergence reserves. Values obtained after participants wore the reference lens and the test lens will be compared.
Measured: From enrollement to the end of the participation at about 16 weeks
Vergence Capacity
Vergence capacity assessed using fusional vergence measurements (in prismatic diopter) obtained under standard clinical conditions. Results after participants wore the reference lens and the test lens will be compared.
Measured: From enrollement to the end of the participation at about 16 weeks
Maximum Comfortable Convex And Concave Lens Power
Maximum convex or concave lens power (in diopter) that can be comfortably accepted while maintaining clear binocular vision. Values obtained after participants wore the reference lens and the small-power lens will be compared.
Measured: From enrollement to the end of the participation at about 16 weeks
Accommodative Lag
Accommodative lag measured in diopters during a near-vision task using an objective method of accommodation assessment. Values obtained after participants wore the reference lens and the test lens will be compared.
Measured: From enrollement to the end of the participation at about 16 weeks
Day effect on Accommodative Lag
Difference in diopter between morning and evening accommodative lag measurements.
Measured: From enrollement to the end of the participation at about 16 weeks
Diurnal change in refraction
Difference between morning and evening refraction measurements. Diurnal changes will be compared between the reference lens and the small-power lens conditions.
Measured: From enrollement to the end of the participation at about 16 weeks
Day effect on near phoria
Difference between morning and evening measurements of near phoria (in prismatic diopter). Diurnal changes will be compared between the reference lens and the small-power lens conditions.
Measured: From enrollement to the end of the participation at about 16 weeks
Day effect on Sheard Criterion
Difference between morning and evening Sheard criterion values. Diurnal changes will be compared between the reference lens and the small-power lens conditions.
Measured: From enrollement to the end of the participation at about 16 weeks
Day effect on AC/A ratio
Difference between morning and evening accommodative convergence to accommodation (AC/A) ratio measurements. Diurnal changes will be compared between the reference lens and the small-power lens conditions.
Measured: From enrollement to the end of the participation at about 16 weeks
Diurnal change in Fusional Vergence Reserves
Difference in prismatic diopter between morning and evening fusional vergence reserve measurements. Diurnal changes will be compared between the reference lens and the small-power lens conditions.
Measured: From enrollement to the end of the participation at about 16 weeks
Diurnal Change in Binocular Accommodative Facility
Difference between morning and evening binocular accommodative facility measurements expressed in cycles per minute. Diurnal changes will be compared between the reference lens and the small-power lens conditions.
Measured: From enrollement to the end of the participation at about 16 weeks
Diurnal Change in Monocular Accommodative Facility
Difference between morning and evening monocular accommodative facility measurements expressed in cycles per minute. Diurnal changes will be compared between the reference lens and the small-power lens conditions.
Measured: From enrollement to the end of the participation at about 16 weeks
Association Between Lens Satisfaction and Refractive Measures
Association between participant satisfaction scores, cycloplegic refraction measurements, and subjective refraction measurements evaluated at the end of the study.
Measured: From enrollment to the end of the participation at about 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859917
- Sponsor's protocol ID
- WS10412
- Acronym
- BIPBIP
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Small Power Addition Lens on the Accommodative and Binocular Profiles
- ClinicalTrials.gov ID
- NCT07859917
- Acronym / sponsor ID
- BIPBIP / WS10412
- Conditions
- Healthy Young Adults, Accommodation Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Oct 2026 (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 clinical study aims to understand how glasses with a small reading addition affect the way the eyes focus and work together in young adults with normal near vision.
Some people experience focusing difficulties or visual discomfort during near-vision activities such as reading or using digital devices. This study will evaluate whether glasses with a small reading addition can help reduce these difficulties and improve visual comfort.
Researchers will compare two different pairs of glasses designed to provide additional support for near vision. They will assess how each pair affects eye focusing and eye coordination using standard optometric examinations.
Participants will:
- Wear three pairs of glasses, each for approximately 4 weeks.
- Complete eye examinations to evaluate focusing ability and eye coordination.
- Answer questionnaires about visual comfort, eye strain, and overall quality of vision.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st worn pair of glasses : Reference / 2nd worn pair of glasses : Test | Experimental | Device: Eye exam, Other: Questionnaires, Device: Washout lenses, Device: Reference lenses, Device: Test lensesThe very first pair of lenses worn before the experimental arm are washout lenses : Standard single-vision spectacle lenses prescribed according to each participant's refractive error and worn during the washout period before allocation to the study lenses. |
| 1st worn pair of glasses : Test / 2nd worn pair of glasses : Reference | Experimental | Device: Eye exam, Other: Questionnaires, Device: Washout lenses, Device: Reference lenses, Device: Test lensesThe very first pair of lenses worn before the experimental arm are washout lenses : Standard single-vision spectacle lenses prescribed according to each participant's refractive error and worn during the washout period before allocation to the study lenses. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 1.Voluntary person, fluent in English willing to follow the protocol, able to read and understand the information form and give his free and informed consent
- 2.Aged between 18 and 35 years old
- 3.Non-presbyopic
- 4.Wears glasses for at least 6 hours per day
- 5.Distance refractive error (Sphere) within the range of [-6.00D to +3.00D] (with cylinder in the negative form)
Key exclusion criteria (15 listed)
- 1.Pregnant woman or nursing
- 2.Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent and persons admitted to a health or social institution for purposes other than research
- 3.Adults who are unwilling or unable to express consent
- 4.Participant in exclusion period from another study
- 5.Persons wearing or that have previously worn any type of anti-fatigue or lenses with a boost
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 |
|---|---|---|
| Eye examAn optometric eye exam | Device | 1st worn pair of glasses : Reference / 2nd worn pair of glasses : Test, 1st worn pair of glasses : Test / 2nd worn pair of glasses : Reference |
| QuestionnairesQuestionnaires on the eye fatigue and the quality of vision | Other | 1st worn pair of glasses : Reference / 2nd worn pair of glasses : Test, 1st worn pair of glasses : Test / 2nd worn pair of glasses : Reference |
| Washout lensesAlso: Single Vision Stylis Cz SapphStandard single-vision spectacle lenses prescribed according to each participant's refractive error and worn during the washout period before allocation to the study lenses. | Device | 1st worn pair of glasses : Reference / 2nd worn pair of glasses : Test, 1st worn pair of glasses : Test / 2nd worn pair of glasses : Reference |
| Reference lensesSpectacles lenses optimized near vision lenses for the comparator | Device | 1st worn pair of glasses : Reference / 2nd worn pair of glasses : Test, 1st worn pair of glasses : Test / 2nd worn pair of glasses : Reference |
| Test lensesSpectacles lenses optimized near vision lenses for the test | Device | 1st worn pair of glasses : Reference / 2nd worn pair of glasses : Test, 1st worn pair of glasses : Test / 2nd worn pair of glasses : Reference |
Primary outcome
Accommodative facility difference
Time frame: From enrollement to the end of the participation at about 16 weeks
Measurement of the accommodative facility to understand the flexibility of the accommodation. It will be measured in cycle per minute (cpm) using a +/-2.00D flipper lens test at 40cm according to standard clinical accommodative facility testing procedures. Lenses are placed in front of the eyes to stimulated or not the accommodation on a text. The main goal of the participant is to keep clear and single the target while switching between the accommodative lenses and the non accommodative lenses. The results obtained after the wearing period of each lenses will be compared together.
18 secondary outcomes
Visual fatigue questionnaire score
Time frame: From enrollement to the end of the participation at about 16 weeks
Visual Comfort Questionnaire Score
Time frame: From enrollement to the end of the participation at about 16 weeks
Vision Quality Questionnaire Score
Time frame: From enrollement to the end of the participation at about 16 weeks
Participant Lens Preference
Time frame: From enrollement to the end of the participation at about 16 weeks
Near Phoria
Time frame: From enrollement to the end of the participation at about 16 weeks
Sheard Criterion
Time frame: From enrollement to the end of the participation at about 16 weeks
Vergence Capacity
Time frame: From enrollement to the end of the participation at about 16 weeks
Maximum Comfortable Convex And Concave Lens Power
Time frame: From enrollement to the end of the participation at about 16 weeks
Accommodative Lag
Time frame: From enrollement to the end of the participation at about 16 weeks
Day effect on Accommodative Lag
Time frame: From enrollement to the end of the participation at about 16 weeks
Diurnal change in refraction
Time frame: From enrollement to the end of the participation at about 16 weeks
Day effect on near phoria
Time frame: From enrollement to the end of the participation at about 16 weeks
Day effect on Sheard Criterion
Time frame: From enrollement to the end of the participation at about 16 weeks
Day effect on AC/A ratio
Time frame: From enrollement to the end of the participation at about 16 weeks
Diurnal change in Fusional Vergence Reserves
Time frame: From enrollement to the end of the participation at about 16 weeks
Diurnal Change in Binocular Accommodative Facility
Time frame: From enrollement to the end of the participation at about 16 weeks
Diurnal Change in Monocular Accommodative Facility
Time frame: From enrollement to the end of the participation at about 16 weeks
Association Between Lens Satisfaction and Refractive Measures
Time frame: From enrollment to the end of the participation at about 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye exam, Questionnaires and Washout lenses in people with Healthy Young Adults and Accommodation Disorder, run by Essilor International at 1 site in United Kingdom.
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 11 inclusion and 15 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: opening soon, as of the sponsor's last update on 6 Oct 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Conway, PhD (+44 20 7040 8392, miriam.conway.1@city.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accommodative facility difference (time frame: From enrollement to the end of the participation at about 16 weeks). 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 Oct 2026.