ClinicalTrials.gg
Not yet recruitingNCT07859917BIPBIPUpdated Oct 6, 2026

Study in Young Adults to Understand How Glasses With a Small Reading Addition Affect Focusing and Eye Coordination During Vision Tasks

An interventional study of Eye exam and Questionnaires in Healthy Young Adults and Accommodation Disorder, sponsored by Essilor International. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Essilor International · Not applicable, Interventional, and Supportive care

Updated Oct 6, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Healthy Young Adults
  • Accommodation Disorder
03

In context

Lead sponsor

Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1.Voluntary person, fluent in English willing to follow the protocol, able to read and understand the information form and give his free and
  • 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
  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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 to cyclopentolate 1% or its
  • 15.Known risk of angle-closure glaucoma.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    1st worn pair of glasses : Reference / 2nd worn pair of glasses : Test

    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.

    Device: Eye exam · Other: Questionnaires · Device: Washout lenses · Device: Reference lenses · Device: Test lenses

  • Experimental
    1st worn pair of glasses : Test / 2nd worn pair of glasses : Reference

    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.

    Device: Eye exam · Other: Questionnaires · Device: Washout lenses · Device: Reference lenses · Device: Test lenses

Interventions

  • DeviceEye exam

    An optometric eye exam

  • OtherQuestionnaires

    Questionnaires on the eye fatigue and the quality of vision

  • DeviceWashout 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.

    Also known as: Single Vision Stylis Cz Sapph

  • DeviceReference lenses

    Spectacles lenses optimized near vision lenses for the comparator

  • DeviceTest lenses

    Spectacles lenses optimized near vision lenses for the test

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

Secondary outcomes

  1. 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

    Time frame: From enrollement to the end of the participation at about 16 weeks

  2. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  3. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  4. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  5. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  6. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  7. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  8. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  9. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  10. Day effect on Accommodative Lag

    Difference in diopter between morning and evening accommodative lag measurements.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  11. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  12. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  13. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  14. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  15. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  16. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  17. 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.

    Time frame: From enrollement to the end of the participation at about 16 weeks

  18. 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.

    Time frame: From enrollment to the end of the participation at about 16 weeks

07

Study locations

1 site
  • City St Georges's, University of London
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2026
First posted
Oct 6, 2026
StartEst.
Sep 2026
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07859917
Responsible party
Sponsor
First posted
Oct 6, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 6, 2026

Study contacts

Miriam Conway, PhD
Contact
miriam.conway.1@city.ac.uk
+44 20 7040 8392

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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